TWINJECT/ADRENACLICK
Report
- Report Number
- 3002919960-2024-00032
- Event Type
- Malfunction
- Date Received
- August 2, 2024
- Date of Event
- July 20, 2024
- Report Date
- October 3, 2024
- Product Code
- PQX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
SEIZURES [SEIZURE] THE NEEDLE DID NOT COME OUT [DEVICE FAILURE] MEDICATION DID NOT ADMINISTERED INTO BODY HOWEVER NEEDLE CAME OUT [DEVICE DELIVERY SYSTEM ISSUE] EMOTIONAL STRESS [EMOTIONAL DISORDER]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE FAILURE AND NO ADVERSE EVENT IN A 46-YEAR-OLD FEMALE PATIENT (RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS 46 YEARS. ON (B)(6) 2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA AN EMAIL CONCERNING ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS BEING TREATED WITH TWINJECT (EPINEPHRINE AUTO-INJECTOR) 0.3 MILLIGRAM (NDC: 0115-1594-30, LOT NO: G240202X, AND EXPIRATION DATE: AUG-2025) (DOSE, FREQUENCY, ROUTE, AND THERAPY DATES WERE NOT REPORTED) FOR ANAPHYLACTIC REACTION. CONCURRENT CONDITIONS INCLUDED ANAPHYLACTIC REACTION. CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES/SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE WAS NOT REPORTED. LABORATORY TEST WERE NOT REPORTED. ON (B)(6) 2024, THE PATIENT RECEIVED A SEALED MEDICATION BOX FROM PHARMACY AND ON (B)(6) 2024 SHE EXPERIENCED ANAPHYLACTIC REACTION SO SHE USED THE FIRST EPINEPHRINE AND SHE OBSERVED THAT THE NEEDLE DID NOT COME OUT AND CONFIRMED THAT SHE USED THE 2ND EPINEPHRINE, AND IT WORKED FINE AND SHE RECOVERED. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE AND NO ADVERSE EVENT WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 07-AUG-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON (B)(6) 2024, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT G240202X, ¿NEEDLE DID NOT COME OUT¿. THE INVESTIGATION COMPLAINT SUB-TYPE BASED ON THE COMPLAINT INFORMATION WAS DETERMINED TO BE FOR ¿FAILURE TO FIRE¿. THE CMO PFIZER INVESTIGATION WAS NOT WARRANTED AS THE COMPLAINT WAS RELATED TO THE ASSEMBLY OF THE DEVICE AT PHILLIPS. AN INVESTIGATION WAS PERFORMED BY PHILLIPS ON THE SUBJECT LOT. AFTER REVIEWING THE MANUFACTURING CONTROLS IN PLACE, PMM DOES NOT SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT (B)(4) AND THE MANUFACTURING PROCESS AT PMM. ALL IN-PROCESS TESTING MET ACCEPTABLE CRITERIA, THERE WERE NO DEVIATIONS OR DISCREPANCIES FOUND DURING ASSEMBLY OF THIS LOT THAT COULD HAVE LED TO THE DEFECT REPORTED BY THE CUSTOMER. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR LOT G240202X FOR THE PAST 24 MONTHS. THERE HAVE BEEN (B)(4) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY ¿FAILURE TO FIRE¿ IN THE PAST 24 MONTHS. NONE OF THE (B)(4) SIMILAR COMPLAINTS WERE ATTRIBUTED TO THE MANUFACTURING PROCESS. RETAIN REVIEW CONFORMED, SAMPLE TESTED FIRE PROPERLY AND DELIVERED A DOSE. BASED ON THE RETAIN REVIEW THE REPORTED COMPLAINT OF WAS NOT CONFIRMED. A REVIEW OF THE PFMEA WAS COMPLETED TO CONFIRM IF THE FAILURE MODE IS CAPTURED WITHIN THE CURRENT ASSEMBLY PROCESS. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION; HENCE THE COMPLAINT COULD NOT BE CONFIRMED. REVIEW OF THE INSTRUCTIONS FOR USE WAS PERFORMED, ¿PULL OFF BOTH BLUE CAPS. PUT THE RED TIP AGAINST THE MIDDLE OF THE OUTER THIGH AT A 90 DEGREE ANGLE. PRESS DOWN HARD AND HOLD FIRMLY AGAINST THIGH FOR APPROXIMATELY TEN (10) SECONDS TO DELIVER THE MEDICINE. ONLY INJECT INTO THE MIDDLE OF THE OUTER THIGH. CHECK THE RED TIP. THE INJECTION IS COMPLETE AND YOU HAVE RECEIVED THE CORRECT DOSE OF THE MEDICINE IF YOU SEE THE NEEDLE STICKING OUT OF THE RED TIP. IF YOU DO NOT SEE THE NEEDLE REPEAT STEPS. THE INSTRUCTIONS FOR USE CLEARLY DETAIL THE STEPS FOR ADMINISTRATION OF THE DEVICE. AS THERE ARE LIMITED DETAILS ASSOCIATED WITH THE REPORTED COMPLAINT AND THE COMPLAINT SAMPLE WAS NOT RETURNED, A ROOT CAUSE RELATED TO USER ERROR COULD NOT BE DETERMINED. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG; LOT G240202X FOR THE COMPLAINT CATEGORY ¿ FAILURE TO FIRE, FOR THE REPORTED COMPLAINT ¿NEEDLE DID NOT COME OUT¿ CONFIRMED THAT THE AUTO-INJECTORS WERE MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS. THE EVALUATION OF THE RETAIN SAMPLE CONFORMED AND MET SPECIFICATION. THE COMPLAINT SAMPLE EVALUATION WAS NOT RETURNED FOR EVALUATION; HENCE THE COMPLAINT WAS NOT CONFIRMED. THERE WERE NO ISSUES RELATED TO THE MANUFACTURING PROCESS THAT WERE DETERMINED TO BE ATTRIBUTED TO THE REPORTED COMPLAINT. THE INVESTIGATION CONCLUDED THAT THE LOT RELEASED TO MARKET WAS MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS AND SPECIFICATIONS. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE AND NO ADVERSE EVENT WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS CASE HAS DEVICE COMPLAINT ASSOCIATED. THE INVESTIGATION REPORT WAS ASSESSED NOT TO HAVE THE POSSIBILITY OF CAUSING ANY FUTURE HARM TO OTHER USERS OF THE PRODUCT. SIGNIFICANT FOLLOW UP (#2) INFORMATION WAS RECEIVED ON 29-AUG-2024. FOLLOW-UP INFORMATION WAS RECEIVED FROM THE PATIENT VIA VOICE MAIL AND TELEPHONIC CALL. NEW INFORMATION INCLUDED ADDITIONAL EVENTS DEVICE DELIVERY SYSTEM ISSUE, EMOTIONAL DISORDER, AND SEIZURE, ADDITIONAL DOSAGE REGIMEN, LOT NO, EXPIRATION DATE, CURRENT CONDITION, AND ALLERGY WERE UPDATED. THE PATIENT WAS BEING TREATED WITH TWINJECT (EPINEPHRINE AUTO-INJECTOR) 0.3 MILLIGRAM (NDC: 0115-1594-30 LOT NO: G240305X AND GT40611X, AND EXPIRATION DATE: 31-OCT-2025, FEB-2025). CONCURRENT CONDITIONS INCLUDED MAST CELL ACTIVATION SYNDROME. ALLERGY INCLUDED LATEX ALLERGY. THE PATIENT 02 MISFIRED EPIPEN ADRENLICK GENERIC SAME LOT SAME NDC NUMBER FROM SAME BOX BECAUSE OF THIS ENDED UP IN ER ABOUT (B)(4) WEEKS AGO AND DOWN WITH (B)(4) EPIPENS AND LEFT WITH 01 CANNOT REFILL. THE PATIENT WAS SUFFERING MAST CELL ACTIVATION SYNDROME WHICH CAN CAUSE ANAPHYLAXIS REACTION FOR ANYTHING AND EVERYTHING AT ANY GIVEN TIME AND ALSO ALLERGIC TO LATEX HOPING THAT MULTIPLE DERIVATIVES AND MANY OTHER THINGS THAT REQUIRE EPIPEN, PATIENT SUPPOSED TO HAVE THREE OR FOUR TIMES AT ALL TIME, PATIENT CANNOT FILL BECAUSE OF INSURANCE. ON AN UNKNOWN DATE OF (B)(6) 2024 THE PATIENT RECEIVED A COMPLETELY SEALED EPINEPHRINE INJECTION USP (AUTO-INJECTOR) FROM PHARMACY. ON UNKNOWN DATE SHE HAD EXPERIENCED ANAPHYLACTIC REACTIONS, AND SHE HAD ADMINISTERED THE MEDICATION, AND IT WAS MISFIRED AS MEDICATION DID NOT ADMINISTERED INTO BODY HOWEVER NEEDLE CAME OUT, IN THE LAST FIVE MONTHS (B)(4) EPINEPHRINE INJECTION USP WERE MISFIRED WITHIN THIS MONTH 03 EPINEPHRINE INJECTION USP (AUTO-INJECTOR) MISFIRED, AND SHE WENT FOR ER VISIT ON UNKNOWN DATE. SHE STATED THAT BECAUSE OF THIS INCIDENT SHE HAS EMOTIONAL STRESS AND SEIZURES. THE PATIENT REQUESTED REPLACEMENT FOR 05 EPINEPHRINE INJECTION. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE, AND DEVICE DELIVERY SYSTEM ISSUE WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO EMOTIONAL DISORDER AND SEIZURE WAS UNKNOWN. DE-CHALLENGE AND RE-CHALLENGE WERE ALSO UNKNOWN. THE OUTCOME OF THE EVENTS SEIZURE, DEVICE FAILURE, DEVICE DELIVERY SYSTEM ISSUE AND EMOTIONAL DISORDER WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF SEIZURE, DEVICE FAILURE, DEVICE DELIVERY SYSTEM ISSUE AND EMOTIONAL DISORDER WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
THE NEEDLE DID NOT COME OUT [DEVICE FAILURE] NO ADVERSE EVENT [NO ADVERSE EVENT] CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE FAILURE AND NO ADVERSE EVENT IN A 46-YEAR-OLD FEMALE PATIENT (RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS 46 YEARS. ON 23-JUL-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA AN EMAIL CONCERNING ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS BEING TREATED WITH TWINJECT (EPINEPHRINE AUTO-INJECTOR) 0.3 MILLIGRAM (NDC: I 0115-1594-30, LOT NO: G240202X, AND EXPIRATION DATE: AUG-2025) (DOSE, FREQUENCY, ROUTE, AND THERAPY DATES WERE NOT REPORTED) FOR ANAPHYLACTIC REACTION. CONCURRENT CONDITIONS INCLUDED ANAPHYLACTIC REACTION. CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES/SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE WAS NOT REPORTED. LABORATORY TEST WERE NOT REPORTED. ON 19-JUL-2024, THE PATIENT RECEIVED A SEALED MEDICATION BOX FROM PHARMACY AND ON 20-JUL-2024 SHE EXPERIENCED ANAPHYLACTIC REACTION SO SHE USED THE FIRST EPINEPHRINE AND SHE OBSERVED THAT THE NEEDLE DID NOT COME OUT AND CONFIRMED THAT SHE USED THE 2ND EPINEPHRINE, AND IT WORKED FINE AND SHE RECOVERED. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE AND NO ADVERSE EVENT WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
THE NEEDLE DID NOT COME OUT [DEVICE FAILURE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE FAILURE AND NO ADVERSE EVENT IN A 46-YEAR-OLD FEMALE PATIENT (RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS 46 YEARS. ON (B)(6) -2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA AN EMAIL CONCERNING ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS BEING TREATED WITH TWINJECT (EPINEPHRINE AUTO-INJECTOR) 0.3 MILLIGRAM (NDC: (B)(4), LOT NO: G240202X, AND EXPIRATION DATE: AUG-2025) (DOSE, FREQUENCY, ROUTE, AND THERAPY DATES WERE NOT REPORTED) FOR ANAPHYLACTIC REACTION. CONCURRENT CONDITIONS INCLUDED ANAPHYLACTIC REACTION. CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES/SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE WAS NOT REPORTED. LABORATORY TEST WERE NOT REPORTED. ON (B)(6)2024, THE PATIENT RECEIVED A SEALED MEDICATION BOX FROM PHARMACY AND ON (B)(6)2024 SHE EXPERIENCED ANAPHYLACTIC REACTION SO SHE USED THE FIRST EPINEPHRINE AND SHE OBSERVED THAT THE NEEDLE DID NOT COME OUT AND CONFIRMED THAT SHE USED THE 2ND EPINEPHRINE, AND IT WORKED FINE AND SHE RECOVERED. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE AND NO ADVERSE EVENT WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON (B)(6) 2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON (B)(6) 2024, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT G240202X, ¿NEEDLE DID NOT COME OUT¿. THE INVESTIGATION COMPLAINT SUB-TYPE BASED ON THE COMPLAINT INFORMATION WAS DETERMINED TO BE FOR ¿FAILURE TO FIRE¿. THE CMO PFIZER INVESTIGATION WAS NOT WARRANTED AS THE COMPLAINT WAS RELATED TO THE ASSEMBLY OF THE DEVICE AT PHILLIPS. AN INVESTIGATION WAS PERFORMED BY PHILLIPS ON THE SUBJECT LOT. AFTER REVIEWING THE MANUFACTURING CONTROLS IN PLACE, PMM DOES NOT SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT (B)(4) AND THE MANUFACTURING PROCESS AT PMM. ALL IN-PROCESS TESTING MET ACCEPTABLE CRITERIA, THERE WERE NO DEVIATIONS OR DISCREPANCIES FOUND DURING ASSEMBLY OF THIS LOT THAT COULD HAVE LED TO THE DEFECT REPORTED BY THE CUSTOMER. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR LOT G240202X FOR THE PAST 24 MONTHS. THERE HAVE BEEN (B)(4) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY ¿FAILURE TO FIRE¿ IN THE PAST 24 MONTHS. NONE OF THE (B)(4) SIMILAR COMPLAINTS WERE ATTRIBUTED TO THE MANUFACTURING PROCESS. RETAIN REVIEW CONFORMED, SAMPLE TESTED FIRE PROPERLY AND DELIVERED A DOSE. BASED ON THE RETAIN REVIEW THE REPORTED COMPLAINT OF WAS NOT CONFIRMED. A REVIEW OF THE PFMEA WAS COMPLETED TO CONFIRM IF THE FAILURE MODE IS CAPTURED WITHIN THE CURRENT ASSEMBLY PROCESS. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION; HENCE THE COMPLAINT COULD NOT BE CONFIRMED. REVIEW OF THE INSTRUCTIONS FOR USE WAS PERFORMED, ¿PULL OFF BOTH BLUE CAPS. PUT THE RED TIP AGAINST THE MIDDLE OF THE OUTER THIGH AT A 90 DEGREE ANGLE. PRESS DOWN HARD AND HOLD FIRMLY AGAINST THIGH FOR APPROXIMATELY TEN (10) SECONDS TO DELIVER THE MEDICINE. ONLY INJECT INTO THE MIDDLE OF THE OUTER THIGH. CHECK THE RED TIP. THE INJECTION IS COMPLETE AND YOU HAVE RECEIVED THE CORRECT DOSE OF THE MEDICINE IF YOU SEE THE NEEDLE STICKING OUT OF THE RED TIP. IF YOU DO NOT SEE THE NEEDLE REPEAT STEPS. THE INSTRUCTIONS FOR USE CLEARLY DETAIL THE STEPS FOR ADMINISTRATION OF THE DEVICE. AS THERE ARE LIMITED DETAILS ASSOCIATED WITH THE REPORTED COMPLAINT AND THE COMPLAINT SAMPLE WAS NOT RETURNED, A ROOT CAUSE RELATED TO USER ERROR COULD NOT BE DETERMINED. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG; LOT G240202X FOR THE COMPLAINT CATEGORY ¿ FAILURE TO FIRE, FOR THE REPORTED COMPLAINT ¿NEEDLE DID NOT COME OUT¿ CONFIRMED THAT THE AUTO-INJECTORS WERE MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS. THE EVALUATION OF THE RETAIN SAMPLE CONFORMED AND MET SPECIFICATION. THE COMPLAINT SAMPLE EVALUATION WAS NOT RETURNED FOR EVALUATION; HENCE THE COMPLAINT WAS NOT CONFIRMED. THERE WERE NO ISSUES RELATED TO THE MANUFACTURING PROCESS THAT WERE DETERMINED TO BE ATTRIBUTED TO THE REPORTED COMPLAINT. THE INVESTIGATION CONCLUDED THAT THE LOT RELEASED TO MARKET WAS MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS AND SPECIFICATIONS. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE AND NO ADVERSE EVENT WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS CASE HAS DEVICE COMPLAINT ASSOCIATED. THE INVESTIGATION REPORT WAS ASSESSED NOT TO HAVE THE POSSIBILITY OF CAUSING ANY FUTURE HARM TO OTHER USERS OF THE PRODUCT.
SEIZURES [SEIZURE] THE NEEDLE DID NOT COME OUT [DEVICE FAILURE] MEDICATION DID NOT ADMINISTERED INTO BODY HOWEVER NEEDLE CAME OUT [DEVICE DELIVERY SYSTEM ISSUE] EMOTIONAL STRESS [EMOTIONAL DISORDER]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE FAILURE AND NO ADVERSE EVENT IN A 46-YEAR-OLD FEMALE PATIENT (RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS 46 YEARS. ON (B)(6)2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA AN EMAIL CONCERNING ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS BEING TREATED WITH TWINJECT (EPINEPHRINE AUTO-INJECTOR) 0.3 MILLIGRAM (NDC: 0115-1594-30, LOT NO: G240202X, AND EXPIRATION DATE: AUG-2025) (DOSE, FREQUENCY, ROUTE, AND THERAPY DATES WERE NOT REPORTED) FOR ANAPHYLACTIC REACTION. CONCURRENT CONDITIONS INCLUDED ANAPHYLACTIC REACTION. CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES/SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE WAS NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. ON (B)(6) 2024, THE PATIENT RECEIVED A SEALED MEDICATION BOX FROM PHARMACY AND ON (B)(6)2024 SHE EXPERIENCED ANAPHYLACTIC REACTION SO SHE USED THE FIRST EPINEPHRINE AND SHE OBSERVED THAT THE NEEDLE DID NOT COME OUT AND CONFIRMED THAT SHE USED THE 2ND EPINEPHRINE, AND IT WORKED FINE AND SHE RECOVERED. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE AND NO ADVERSE EVENT WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 07-AUG-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON (B)(6)2024, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT G240202X, ¿NEEDLE DID NOT COME OUT¿. THE INVESTIGATION COMPLAINT SUB-TYPE BASED ON THE COMPLAINT INFORMATION WAS DETERMINED TO BE FOR ¿FAILURE TO FIRE¿. THE CMO PFIZER INVESTIGATION WAS NOT WARRANTED AS THE COMPLAINT WAS RELATED TO THE ASSEMBLY OF THE DEVICE AT PHILLIPS. AN INVESTIGATION WAS PERFORMED BY PHILLIPS ON THE SUBJECT LOT. AFTER REVIEWING THE MANUFACTURING CONTROLS IN PLACE, PMM DOES NOT SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT (B)(4) AND THE MANUFACTURING PROCESS AT PMM. ALL IN-PROCESS TESTING MET ACCEPTABLE CRITERIA, THERE WERE NO DEVIATIONS OR DISCREPANCIES FOUND DURING ASSEMBLY OF THIS LOT THAT COULD HAVE LED TO THE DEFECT REPORTED BY THE CUSTOMER. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR LOT G240202X FOR THE PAST 24 MONTHS. THERE HAVE BEEN (B)(4) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY ¿FAILURE TO FIRE¿ IN THE PAST 24 MONTHS. NONE OF THE (B)(4) SIMILAR COMPLAINTS WERE ATTRIBUTED TO THE MANUFACTURING PROCESS. RETAIN REVIEW CONFORMED, SAMPLE TESTED FIRE PROPERLY AND DELIVERED A DOSE. BASED ON THE RETAIN REVIEW THE REPORTED COMPLAINT OF WAS NOT CONFIRMED. A REVIEW OF THE PFMEA WAS COMPLETED TO CONFIRM IF THE FAILURE MODE IS CAPTURED WITHIN THE CURRENT ASSEMBLY PROCESS. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION; HENCE THE COMPLAINT COULD NOT BE CONFIRMED. REVIEW OF THE INSTRUCTIONS FOR USE WAS PERFORMED, ¿PULL OFF BOTH BLUE CAPS. PUT THE RED TIP AGAINST THE MIDDLE OF THE OUTER THIGH AT A 90 DEGREE ANGLE. PRESS DOWN HARD AND HOLD FIRMLY AGAINST THIGH FOR APPROXIMATELY TEN (10) SECONDS TO DELIVER THE MEDICINE. ONLY INJECT INTO THE MIDDLE OF THE OUTER THIGH. CHECK THE RED TIP. THE INJECTION IS COMPLETE AND YOU HAVE RECEIVED THE CORRECT DOSE OF THE MEDICINE IF YOU SEE THE NEEDLE STICKING OUT OF THE RED TIP. IF YOU DO NOT SEE THE NEEDLE REPEAT STEPS. THE INSTRUCTIONS FOR USE CLEARLY DETAIL THE STEPS FOR ADMINISTRATION OF THE DEVICE. AS THERE ARE LIMITED DETAILS ASSOCIATED WITH THE REPORTED COMPLAINT AND THE COMPLAINT SAMPLE WAS NOT RETURNED, A ROOT CAUSE RELATED TO USER ERROR COULD NOT BE DETERMINED. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG; LOT G240202X FOR THE COMPLAINT CATEGORY ¿ FAILURE TO FIRE, FOR THE REPORTED COMPLAINT ¿NEEDLE DID NOT COME OUT¿ CONFIRMED THAT THE AUTO-INJECTORS WERE MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS. THE EVALUATION OF THE RETAIN SAMPLE CONFORMED AND MET SPECIFICATION. THE COMPLAINT SAMPLE EVALUATION WAS NOT RETURNED FOR EVALUATION; HENCE THE COMPLAINT WAS NOT CONFIRMED. THERE WERE NO ISSUES RELATED TO THE MANUFACTURING PROCESS THAT WERE DETERMINED TO BE ATTRIBUTED TO THE REPORTED COMPLAINT. THE INVESTIGATION CONCLUDED THAT THE LOT RELEASED TO MARKET WAS MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS AND SPECIFICATIONS. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE AND NO ADVERSE EVENT WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS CASE HAS DEVICE COMPLAINT ASSOCIATED. THE INVESTIGATION REPORT WAS ASSESSED NOT TO HAVE THE POSSIBILITY OF CAUSING ANY FUTURE HARM TO OTHER USERS OF THE PRODUCT. SIGNIFICANT FOLLOW UP (#2) INFORMATION WAS RECEIVED ON 29-AUG-2024. FOLLOW-UP INFORMATION WAS RECEIVED FROM THE PATIENT VIA VOICE MAIL AND TELEPHONIC CALL. NEW INFORMATION INCLUDED ADDITIONAL EVENTS DEVICE DELIVERY SYSTEM ISSUE, EMOTIONAL DISORDER, AND SEIZURE, ADDITIONAL DOSAGE REGIMEN, LOT NO, EXPIRATION DATE, CURRENT CONDITION, AND ALLERGY WERE UPDATED. THE PATIENT WAS BEING TREATED WITH TWINJECT (EPINEPHRINE AUTO-INJECTOR) 0.3 MILLIGRAM (NDC: 0115-1694-30, LOT NO: G240305X AND GT40611X, AND EXPIRATION DATE: 31-OCT-2025, FEB-2025). CONCURRENT CONDITIONS INCLUDED MAST CELL ACTIVATION SYNDROME. ALLERGY INCLUDED LATEX ALLERY. THE PATIENT (B)(4) MISFIRED EPIPEN ADRENLICK GENERIC SAME LOT SAME NDC NUMBER FROM SAME BOX BECAUSE OF THIS ENDED UP IN ER ABOUT 02 WEEKS AGO AND DOWN WITH (B)(4) EPIPENS AND LEFT WITH (B)(4) CANNOT REFILL. THE PATIENT WAS SUFFERING MAST CELL ACTIVATION SYNDROME WHICH CAN CAUSE ANAPHYLAXIS REACTION FOR ANYTHING AND EVERYTHING AT ANY GIVEN TIME AND ALSO ALLERGIC TO LATEX HOPING THAT MULTIPLE DERIVATIVES AND MANY OTHER THINGS THAT REQUIRE EPIPEN, PATIENT SUPPOSED TO HAVE THREE OR FOUR TIMES AT ALL TIME, PATIENT CANNOT FILL BECAUSE OF INSURANCE. ON AN UNKNOWN DATE OF (B)(6)2024 THE PATIENT RECEIVED A COMPLETELY SEALED EPINEPHRINE INJECTION USP (AUTO-INJECTOR) FROM PHARMACY. ON UNKNOWN DATE SHE HAD EXPERIENCED ANAPHYLACTIC REACTIONS, AND SHE HAD ADMINISTERED THE MEDICATION, AND IT WAS MISFIRED AS MEDICATION DID NOT ADMINISTERED INTO BODY HOWEVER NEEDLE CAME OUT, IN THE LAST FIVE MONTHS (B)(4) EPINEPHRINE INJECTION USP WERE MISFIRED WITHIN THIS MONTH (B)(4) EPINEPHRINE INJECTION USP (AUTO-INJECTOR) MISFIRED, AND SHE WENT FOR ER VISIT ON UNKNOWN DATE. SHE STATED THAT BECAUSE OF THIS INCIDENT SHE HAS EMOTIONAL STRESS AND SEIZURES. THE PATIENT REQUESTED REPLACEMENT FOR (B)(4) EPINEPHRINE INJECTION. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE, AND DEVICE DELIVERY SYSTEM ISSUE WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO EMOTIONAL DISORDER AND SEIZURE WAS UNKNOWN. DE-CHALLENGE AND RE-CHALLENGE WERE ALSO UNKNOWN. THE OUTCOME OF THE EVENTS SEIZURE, DEVICE FAILURE, DEVICE DELIVERY SYSTEM ISSUE AND EMOTIONAL DISORDER WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF SEIZURE, DEVICE FAILURE, DEVICE DELIVERY SYSTEM ISSUE AND EMOTIONAL DISORDER WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#3) INFORMATION RECEIVED ON 18-SEP-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON (B)(6) 2024, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG LOT G240305X ((B)(6)) EXP DEC 2025 AND ON (B)(6) 2024 AFTER RECEIVING AN ADDITIONAL IN THE RETURNED COMPLAINT SAMPLES, THE INVESTIGATION WAS EXPANDED TO INCLUDE G240611X ((B)(6)) EXP DEC 2025, ¿(B)(4) EPINEPHRINE INJECTION USP (AUTO-INJECTOR) MISFIRED¿. THE INVESTIGATION COMPLAINT SUB-TYPE BASED ON THE COMPLAINT INFORMATION WAS DETERMINED TO BE FOR MEDICINE LEFT IN SYRINGE AND LACK OF EFFECT. THE CMO PFIZER AND CPO PHILLIPS PERFORMED AN INVESTIGATION. G240611X (KC6010) EXP DEC 2025. PFIZER INVESTIGATION: INVESTIGATION ONGOING. PFIZER NOTIFIED ON (B)(6) 2024 TO EXPAND THE INVESTIGATION TO INCLUDE THIS LOT. THIS REPORT WILL BE AMENDED ONCE AMNEAL RECEIVES THE INVESTIGATION. THE CPO PHILLIPS PERFORMED AN INVESTIGATION FOR ¿MEDICINE LEFT IN SYRINGE¿ ON THE EPINEPHRINE AUTO-INJECTOR 0.3 MG LOT G240611X. AFTER REVIEW OF THE MANUFACTURING CONTROLS IN PLACE, PMM DOES NOT SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT (B)(4) AND THE MANUFACTURING PROCESS AT PMM. ALL IN-PROCESS TESTING MET ACCEPTABLE CRITERIA, THERE WERE NO DEVIATIONS OR DISCREPANCIES FOUND DURING ASSEMBLY OF THIS LOT THAT COULD HAVE LED TO THE DEFECT REPORTED BY THE CUSTOMER. ALL IN-PROCESS AND FINAL RELEASE CRITERIA WERE MET FOR THE LOT MANUFACTURED AT PHILLIPS-MEDISIZE. THERE WERE NO ADDITIONAL ANOMALIES NOTED AND THE LOT WAS ACCEPTABLE FOR RELEASE. THERE HAVE BEEN ZERO (0) OTHER COMPLAINTS REPORTED FOR LOT G240611X FOR THE PAST 24 MONTHS. THERE HAVE BEEN (B)(4) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY ¿MEDICINE LEFT IN SYRINGE¿ IN THE PAST 24 MONTHS. THE (B)(4) OTHER SIMILAR COMPLAINTS WERE INVESTIGATED, AND CONCLUDED THEY WERE NOT RELATED TO MANUFACTURING. THE REPORTED COMPLAINT WAS NOT CONFIRMED IN THE RETAIN SAMPLE REVIEW, THE RETAIN SAMPLE CONFORMED. G240305X (CPJT HP1557) EXP DEC 2025. THE CMO PFIZER PERFORMED AN INVESTIGATION FOR LACK OF EFFECT ON THE CPJT LOT HP1557. THE INVESTIGATION INCLUDED REVIEW OF THE INCOMING QUALITY AND MANUFACTURING BATCH RECORDS, DEVIATION INVESTIGATIONS, APRR REVIEW, AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE LACK OF EFFECT. THERE IS NO IMPACT ON PRODUCT QUALITY, REGULATORY COMPLIANCE, VALIDATION, STABILITY, OR PATIENT SAFETY. THERE IS NO IMPACT ON PRODUCT QUALITY. THE COMPLAINT SAMPLE WAS BY THE (B)(4) CUSTOMER ON (B)(6)2023. THE COMPLAINT CONDITION WAS NOT CONFIRMED; THEREFORE, THE ROOT CAUSE CANNOT BE ATTRIBUTED TO MANUFACTURE OR VENDOR PROCESSES. THE ROOT CAUSE WAS NOT DETERMINED TO BE MANUFACTURE OR VENDOR RELATED AS INCOMING QUALITY COMPONENT TESTING, BULK RELEASE TESTING, AND CERTIFICATE OF ANALYSIS AT TIME OF RELEASE WERE ALL DETERMINED TO BE ACCEPTABLE. STORAGE CONDITIONS OR USER ERROR CANNOT BE RULED OUT AS THE ROOT CAUSE. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AS THE COMPLAINT CONDITION WAS NOT DETERMINED TO BE MANUFACTURER OR VENDOR RELATED. THE REPORTED DEFECT IS NOT REPRESENTATIVE OF THE QUALITY OF THE BATCH AND REMAINS ACCEPTABLE FOR FURTHER DISTRIBUTION. THE CPO PHILLIPS PERFORMED AN INVESTIGATION FOR MEDICINE LEFT IN SYRINGE ON THE EPINEPHRINE AUTO-INJECTOR 0.3 MG LOT G240305X. AFTER REVIEW OF THE MANUFACTURING CONTROLS IN PLACE, PMM DOES NOT SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT (B)(4) AND THE MANUFACTURING PROCESS AT PMM. ALL IN-PROCESS TESTING MET ACCEPTABLE CRITERIA, THERE WERE NO DEVIATIONS OR DISCREPANCIES FOUND DURING ASSEMBLY OF THIS LOT THAT COULD HAVE LED TO THE DEFECT REPORTED BY THE CUSTOMER. ALL IN-PROCESS AND FINAL RELEASE CRITERIA WERE MET FOR THE LOT MANUFACTURED AT PHILLIPS-MEDISIZE. THERE WERE NO ADDITIONAL ANOMALIES NOTED AND THE LOT WAS ACCEPTABLE FOR RELEASE. THERE HAVE BEEN ZERO (0) OTHER COMPLAINTS REPORTED FOR LOT G240305X FOR THE PAST 24 MONTHS. THERE HAS BEEN (B)(4) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY MEDICINE LEFT IN SYRINGE IN THE PAST 24 MONTHS. THE (B)(4) OTHER SIMILAR COMPLAINTS WERE INVESTIGATED, AND CONCLUDED THEY WERE NOT RELATED TO MANUFACTURING. THE REPORTED COMPLAINT WAS NOT CONFIRMED IN THE RETAIN SAMPLE REVIEW, THE RETAIN SAMPLE CONFORMED. A REVIEW OF THE PFMEA WAS COMPLETED TO CONFIRM IF THE FAILURE MODE IS CAPTURED WITHIN THE CURRENT ASSEMBLY PROCESS. BASED ON THE INFORMATION PROVIDED FOR THE REPORTED COMPLAINT, MISFIRED, THE PATIENT STATED (B)(4) DEVICES HAD MISFIRED. THE INTAKE INFORMATION WAS REVIEWED, AND THE USER STATED, SHE HAD ADMINISTERED THE MEDICATION, AND IT WAS MISFIRED (MEDICATION DID NOT ADMINISTERED INTO BODY HOWEVER NEEDLE CAME OUT). THE CONCLUSION THAT THE DEVICE DID NOT WORK BASED THE AMOUNT OF FLUID LEFT IN THE GLASS CARTRIDGE? THIS QUESTION WAS ANSWERED YES PER THE QUESTIONNAIRE. BASED ON THIS INFORMATION THE USER MAY HAVE THOUGHT THEY DID NOT RECEIVE THE DOSE DUE TO THE SOLUTION REMAINING IN THE DEVICE. THE IFU STATES, EPINEPHRINE INJECTION, USP 0.3 MG AND EPINEPHRINE INJECTION, USP 0.15 MG EACH CONTAIN 1.1 ML OF EPINEPHRINE SOLUTION. 0.3 ML AND 0.15 ML EPINEPHRINE SOLUTION ARE DISPENSED FOR EPINEPHRINE INJECTION, USP 0.3 MG AND EPINEPHRINE INJECTION, USP 0.15 MG, RESPECTIVELY, WHEN ACTIVATED. THE SOLUTION REMAINING AFTER ACTIVATION IS NOT AVAILABLE FOR FUTURE USE AND SHOULD BE DISCARDED. THE INJECTION IS COMPLETE, AND YOU HAVE RECEIVED THE CORRECT DOSE OF THE MEDICATION IF YOU SEE THE NEEDLE STICKING OUT OF THE RED TIP. IF YOU DO NOT SEE THE NEEDLE REPEAT STEP 2. IN ADDITION, THE IFU STATES, EPINEPHRINE INJECTION IS A SINGLE-USE INJECTABLE DEVICE THAT DELIVERS A FIXED DOSE OF EPINEPHRINE. EPINEPHRINE INJECTION CANNOT BE REUSED. DO NOT ATTEMPT TO REUSE EPINEPHRINE INJECTION AFTER THE DEVICE HAS BEEN ACTIVATED. IT IS NORMAL FOR MOST OF THE MEDICINE TO REMAIN IN THE AUTO-INJECTOR AFTER THE DOSE IS INJECTED. THE CORRECT DOSE HAS BEEN ADMINISTERED IF YOU SEE THE NEEDLE STICKING OUT OF THE RED TIP. YOU MAY NEED TO USE A SECOND INJECTION IF SYMPTOMS CONTINUE OR RECUR. THE COMPLAINT SAMPLE WAS RETURNED ON 12 SEP 24 AND INSPECTED ON 12 SEP 24 FROM THE SAMPLE RETURN KIT PROVIDED BY IMPAX - AMNEAL. THREE (3) 0.3 MG AUTO-INJECTORS WERE RETURNED, WHICH INCLUDED SAMPLES FROM LOT G240305X EXP OCT 2025 (QTY (B)(4)) AND G240611X EXP DEC 2025. BASED ON THE COMPLAINT SAMPLE EVALUATION FOR THE REPORTED COMPLAINT OF "MISFIRED" WAS NOT CONFIRMED IN THE AS ALL DEVICES HAD BEEN FIRED, DELIVERED A DOSE AND WERE ADMINISTERED TO A PATIENT. EVIDENCE OF ALL DEVICES BEING FIRED AND DOSE DELIVERY WERE THE FOLLOWING; THE NEEDLE WAS PROJECTING FROM THE RED NOSE CAP, THE SPRING RELEASE TINES WERE NOT AFFIXED TO THE FIRING BUSHING, THE CARPUJECT HAD APPROXIMATELY 0.8 ML OF SOLUTION REMAINING AND THE DOSE ADJUSTMENT SCREW WAS IN CONTACT WITH THE STOP COLLAR. IN ADDITION, SKIN TISSUE RESIDUE WAS OBSERVED ON THE NEEDLE FOR ALL SAMPLES WHICH CONFIRMED THE DEVICE WAS ADMINISTERED TO THE PATIENT. AS SUCH THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS IDENTIFIED AS A CONFIRMED USER ERROR FOR THE REPORTED ¿MEDICINE LEFT IN SYRINGE AND LACK OF EFFECT, DUE TO NOT FOLLOWING THE IFU FOR CONFIRMATION OF DOSE DELIVERY FOR BOTH SUBJECT LOTS G240305X AND G240611X. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG LOT G240611X FOR THE COMPLAINT CATEGORY - MEDICINE LEFT IN THE SYRINGE AND LACK OF EFFECT, FOR THE REPORTED COMPLAINT CONFIRMED THE IN-PROCESS AND FINAL RELEASE CRITERIA WERE MET FOR THE LOT MANUFACTURED AT PHILLIPS. THE EVALUATION OF THE RETAIN SAMPLE CONFORMED AND MET SPECIFICATION. THE COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED COMPLAINT WAS NOT CONFIRMED FOR LOT G240611X AS THERE WAS EVIDENCE THAT THE DEVICE WAS ADMINISTERED TO THE PATIENT AND DELIVERED A DOSE. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS IDENTIFIED AS A CONFIRMED USER ERROR FOR THE REPORTED ¿MEDICINE LEFT IN SYRINGE AND LACK OF EFFECT, DUE TO NOT FOLLOWING THE IFU FOR CONFIRMATION OF DOSE DELIVERY. THERE WERE NO ISSUES RELATED TO THE MANUFACTURING PROCESS AT PHILIPS FOR LOT G240611X THAT WERE DETERMINED TO BE ATTRIBUTED TO THE REPORTED COMPLAINT. THE INVESTIGATION CONCLUDED LOT G240611X RELEASED TO MARKET WAS MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS AND SPECIFICATIONS. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG LOT G240305X FOR THE COMPLAINT CATEGORY ¿ MEDICINE LEFT IN THE SYRINGE AND LACK OF EFFECT, FOR THE REPORTED COMPLAINT CONFIRMED THE IN-PROCESS AND FINAL RELEASE CRITERIA WERE MET FOR THE LOT MANUFACTURED. THE EVALUATION OF THE RETAIN SAMPLE CONFORMED AND MET SPECIFICATION. THE DRUG PRODUCT FINAL RELEASE TESTING WAS REVIEWED AND MET SPECIFICATION AT THE TIME OF RELEASE. THE COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED COMPLAINT WAS NOT CONFIRMED FOR LOT G240305X AS THERE WAS EVIDENCE THAT THE DEVICE WAS ADMINISTERED TO THE PATIENT AND DELIVERED A DOSE. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS IDENTIFIED AS A CONFIRMED USER ERROR FOR THE REPORTED ¿MEDICINE LEFT IN SYRINGE AND LACK OF EFFECT, DUE TO NOT FOLLOWING THE IFU FOR CONFIRMATION OF DOSE DELIVERY. THERE WERE NO ISSUES RELATED TO THE MANUFACTURING PROCESS FOR LOT G240305X THAT WERE DETERMINED TO BE ATTRIBUTED TO THE REPORTED COMPLAINT. THE INVESTIGATION CONCLUDED LOT G240305X RELEASED TO MARKET WAS MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS AND SPECIFICATIONS. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE, AND DEVICE DELIVERY SYSTEM ISSUE WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO EMOTIONAL DISORDER AND SEIZURE WAS UNKNOWN. DE-CHALLENGE AND RE-CHALLENGE WERE ALSO UNKNOWN. THE OUTCOME OF THE EVENTS SEIZURE, DEVICE FAILURE, DEVICE DELIVERY SYSTEM ISSUE AND EMOTIONAL DISORDER WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF SEIZURE, DEVICE FAILURE, DEVICE DELIVERY SYSTEM ISSUE AND EMOTIONAL DISORDER WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS CASE HAS AEPQC ASSOCIATED. THE INVESTIGATION REPORT WAS ASSESSED NOT TO HAVE THE POSSIBILITY OF CAUSING ANY FUTURE HARM TO OTHER USERS OF THE PRODUCT. THIS SIGNIFICANT FOLLOW UP (#4) INFORMATION RECEIVED ON 20-SEP-2024. NEW INFORMATION RECEIVED INCLUDES AMENDED INVESTIGATION REPORT WAS ATTACHED WITH THIS CASE. THE CMO PFIZER PERFORMED AN INVESTIGATION FOR ¿LACK OF EFFECT¿ ON THE CPJT LOT KC6010. THE INVESTIGATION INCLUDED REVIEW OF THE INCOMING QUALITY AND MANUFACTURING BATCH RECORDS, DEVIATION INVESTIGATIONS, APRR REVIEW, AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE LACK OF EFFECT. THERE IS NO IMPACT ON PRODUCT QUALITY, REGULATORY COMPLIANCE, VALIDATION, STABILITY, OR PATIENT SAFETY. THERE IS NO IMPACT ON PRODUCT QUALITY. THE COMPLAINT SAMPLE WAS BY THE (B)(4) CUSTOMER ON (B)(6)2023. THE COMPLAINT CONDITION WAS NOT CONFIRMED; THEREFORE, THE ROOT CAUSE CANNOT BE ATTRIBUTED TO MANUFACTURE OR VENDOR PROCESSES. THE ROOT CAUSE WAS NOT DETERMINED TO BE MANUFACTURE OR VENDOR RELATED AS INCOMING QUALITY COMPONENT TESTING, BULK RELEASE TESTING, AND CERTIFICATE OF ANALYSIS AT TIME OF RELEASE WERE ALL DETERMINED TO BE ACCEPTABLE. STORAGE CONDITIONS OR USER ERROR CANNOT BE RULED OUT AS THE ROOT CAUSE. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AS THE COMPLAINT CONDITION WAS NOT DETERMINED TO BE MANUFACTURER OR VENDOR RELATED. THE REPORTED DEFECT IS NOT REPRESENTATIVE OF THE QUALITY OF THE BATCH AND REMAINS ACCEPTABLE FOR FURTHER DISTRIBUTION. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE, AND DEVICE DELIVERY SYSTEM ISSUE WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO EMOTIONAL DISORDER AND SEIZURE WAS UNKNOWN. DE-CHALLENGE AND RE-CHALLENGE WERE ALSO UNKNOWN. THE OUTCOME OF THE EVENTS SEIZURE, DEVICE FAILURE, DEVICE DELIVERY SYSTEM ISSUE AND EMOTIONAL DISORDER WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF SEIZURE, DEVICE FAILURE, DEVICE DELIVERY SYSTEM ISSUE AND EMOTIONAL DISORDER WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
SEIZURES [SEIZURE] THE NEEDLE DID NOT COME OUT [DEVICE FAILURE] MEDICATION DID NOT ADMINISTERED INTO BODY HOWEVER NEEDLE CAME OUT [DEVICE DELIVERY SYSTEM ISSUE] EMOTIONAL STRESS [EMOTIONAL DISORDER]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE FAILURE AND NO ADVERSE EVENT IN A 46-YEAR-OLD FEMALE PATIENT (RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS 46 YEARS. ON (B)(6)2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA AN EMAIL CONCERNING ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS BEING TREATED WITH TWINJECT (EPINEPHRINE AUTO-INJECTOR) 0.3 MILLIGRAM (NDC: (B)(4), LOT NO: G240202X, AND EXPIRATION DATE: AUG-2025) (DOSE, FREQUENCY, ROUTE, AND THERAPY DATES WERE NOT REPORTED) FOR ANAPHYLACTIC REACTION. CONCURRENT CONDITIONS INCLUDED ANAPHYLACTIC REACTION. CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES/SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE WAS NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. ON (B)(6)2024, THE PATIENT RECEIVED A SEALED MEDICATION BOX FROM PHARMACY AND ON (B)(6)2024 SHE EXPERIENCED ANAPHYLACTIC REACTION SO SHE USED THE FIRST EPINEPHRINE AND SHE OBSERVED THAT THE NEEDLE DID NOT COME OUT AND CONFIRMED THAT SHE USED THE 2ND EPINEPHRINE, AND IT WORKED FINE AND SHE RECOVERED. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE AND NO ADVERSE EVENT WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 07-AUG-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON (B)(6)2024, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT G240202X, ¿NEEDLE DID NOT COME OUT¿. THE INVESTIGATION COMPLAINT SUB-TYPE BASED ON THE COMPLAINT INFORMATION WAS DETERMINED TO BE FOR ¿FAILURE TO FIRE¿. THE CMO PFIZER INVESTIGATION WAS NOT WARRANTED AS THE COMPLAINT WAS RELATED TO THE ASSEMBLY OF THE DEVICE AT PHILLIPS. AN INVESTIGATION WAS PERFORMED BY PHILLIPS ON THE SUBJECT LOT. AFTER REVIEWING THE MANUFACTURING CONTROLS IN PLACE, PMM DOES NOT SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT (B)(4) AND THE MANUFACTURING PROCESS AT PMM. ALL IN-PROCESS TESTING MET ACCEPTABLE CRITERIA, THERE WERE NO DEVIATIONS OR DISCREPANCIES FOUND DURING ASSEMBLY OF THIS LOT THAT COULD HAVE LED TO THE DEFECT REPORTED BY THE CUSTOMER. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR LOT G240202X FOR THE PAST 24 MONTHS. THERE HAVE BEEN (B)(4) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY ¿FAILURE TO FIRE¿ IN THE PAST 24 MONTHS. NONE OF THE (B)(4) SIMILAR COMPLAINTS WERE ATTRIBUTED TO THE MANUFACTURING PROCESS. RETAIN REVIEW CONFORMED, SAMPLE TESTED FIRE PROPERLY AND DELIVERED A DOSE. BASED ON THE RETAIN REVIEW THE REPORTED COMPLAINT OF WAS NOT CONFIRMED. A REVIEW OF THE PFMEA WAS COMPLETED TO CONFIRM IF THE FAILURE MODE IS CAPTURED WITHIN THE CURRENT ASSEMBLY PROCESS. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION; HENCE THE COMPLAINT COULD NOT BE CONFIRMED. REVIEW OF THE INSTRUCTIONS FOR USE WAS PERFORMED, ¿PULL OFF BOTH BLUE CAPS. PUT THE RED TIP AGAINST THE MIDDLE OF THE OUTER THIGH AT A 90 DEGREE ANGLE. PRESS DOWN HARD AND HOLD FIRMLY AGAINST THIGH FOR APPROXIMATELY TEN (10) SECONDS TO DELIVER THE MEDICINE. ONLY INJECT INTO THE MIDDLE OF THE OUTER THIGH. CHECK THE RED TIP. THE INJECTION IS COMPLETE AND YOU HAVE RECEIVED THE CORRECT DOSE OF THE MEDICINE IF YOU SEE THE NEEDLE STICKING OUT OF THE RED TIP. IF YOU DO NOT SEE THE NEEDLE REPEAT STEPS. THE INSTRUCTIONS FOR USE CLEARLY DETAIL THE STEPS FOR ADMINISTRATION OF THE DEVICE. AS THERE ARE LIMITED DETAILS ASSOCIATED WITH THE REPORTED COMPLAINT AND THE COMPLAINT SAMPLE WAS NOT RETURNED, A ROOT CAUSE RELATED TO USER ERROR COULD NOT BE DETERMINED. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG; LOT G240202X FOR THE COMPLAINT CATEGORY ¿ FAILURE TO FIRE, FOR THE REPORTED COMPLAINT ¿NEEDLE DID NOT COME OUT¿ CONFIRMED THAT THE AUTO-INJECTORS WERE MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS. THE EVALUATION OF THE RETAIN SAMPLE CONFORMED AND MET SPECIFICATION. THE COMPLAINT SAMPLE EVALUATION WAS NOT RETURNED FOR EVALUATION; HENCE THE COMPLAINT WAS NOT CONFIRMED. THERE WERE NO ISSUES RELATED TO THE MANUFACTURING PROCESS THAT WERE DETERMINED TO BE ATTRIBUTED TO THE REPORTED COMPLAINT. THE INVESTIGATION CONCLUDED THAT THE LOT RELEASED TO MARKET WAS MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS AND SPECIFICATIONS. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE AND NO ADVERSE EVENT WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS CASE HAS DEVICE COMPLAINT ASSOCIATED. THE INVESTIGATION REPORT WAS ASSESSED NOT TO HAVE THE POSSIBILITY OF CAUSING ANY FUTURE HARM TO OTHER USERS OF THE PRODUCT. SIGNIFICANT FOLLOW UP (#2) INFORMATION WAS RECEIVED ON 29-AUG-2024. FOLLOW-UP INFORMATION WAS RECEIVED FROM THE PATIENT VIA VOICE MAIL AND TELEPHONIC CALL. NEW INFORMATION INCLUDED ADDITIONAL EVENTS DEVICE DELIVERY SYSTEM ISSUE, EMOTIONAL DISORDER, AND SEIZURE, ADDITIONAL DOSAGE REGIMEN, LOT NO, EXPIRATION DATE, CURRENT CONDITION, AND ALLERGY WERE UPDATED. THE PATIENT WAS BEING TREATED WITH TWINJECT (EPINEPHRINE AUTO-INJECTOR) 0.3 MILLIGRAM ((B)(4), LOT NO: G240305X AND GT40611X, AND EXPIRATION DATE: 31-OCT-2025, FEB-2025). CONCURRENT CONDITIONS INCLUDED MAST CELL ACTIVATION SYNDROME. ALLERGY INCLUDED LATEX ALLERY. THE PATIENT (B)(4) MISFIRED EPIPEN ADRENLICK GENERIC SAME LOT SAME NDC NUMBER FROM SAME BOX BECAUSE OF THIS ENDED UP IN ER ABOUT (B)(4) WEEKS AGO AND DOWN WITH (B)(4) EPIPENS AND LEFT WITH 0(B)(4) CANNOT REFILL. THE PATIENT WAS SUFFERING MAST CELL ACTIVATION SYNDROME WHICH CAN CAUSE ANAPHYLAXIS REACTION FOR ANYTHING AND EVERYTHING AT ANY GIVEN TIME AND ALSO ALLERGIC TO LATEX HOPING THAT MULTIPLE DERIVATIVES AND MANY OTHER THINGS THAT REQUIRE EPIPEN, PATIENT SUPPOSED TO HAVE THREE OR FOUR TIMES AT ALL TIME, PATIENT CANNOT FILL BECAUSE OF INSURANCE. ON AN UNKNOWN DATE OF (B)(6) 2024 THE PATIENT RECEIVED A COMPLETELY SEALED EPINEPHRINE INJECTION USP (AUTO-INJECTOR) FROM PHARMACY. ON UNKNOWN DATE SHE HAD EXPERIENCED ANAPHYLACTIC REACTIONS, AND SHE HAD ADMINISTERED THE MEDICATION, AND IT WAS MISFIRED AS MEDICATION DID NOT ADMINISTERED INTO BODY HOWEVER NEEDLE CAME OUT, IN THE LAST FIVE MONTHS (B)(4) EPINEPHRINE INJECTION USP WERE MISFIRED WITHIN THIS MONTH (B)(4) EPINEPHRINE INJECTION USP (AUTO-INJECTOR) MISFIRED, AND SHE WENT FOR ER VISIT ON UNKNOWN DATE. SHE STATED THAT BECAUSE OF THIS INCIDENT SHE HAS EMOTIONAL STRESS AND SEIZURES. THE PATIENT REQUESTED REPLACEMENT FOR (B)(4) EPINEPHRINE INJECTION. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE, AND DEVICE DELIVERY SYSTEM ISSUE WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO EMOTIONAL DISORDER AND SEIZURE WAS UNKNOWN. DE-CHALLENGE AND RE-CHALLENGE WERE ALSO UNKNOWN. THE OUTCOME OF THE EVENTS SEIZURE, DEVICE FAILURE, DEVICE DELIVERY SYSTEM ISSUE AND EMOTIONAL DISORDER WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF SEIZURE, DEVICE FAILURE, DEVICE DELIVERY SYSTEM ISSUE AND EMOTIONAL DISORDER WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON (B)(6) 2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON (B)(6) 2024, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG LOT G240305X (CPJT HP1557) EXP DEC 2025 AND ON (B)(6) 2024 AFTER RECEIVING AN ADDITIONAL IN THE RETURNED COMPLAINT SAMPLES, THE INVESTIGATION WAS EXPANDED TO INCLUDE G240611X (KC6010) EXP DEC 2025, ¿(B)(4) EPINEPHRINE INJECTION USP (AUTO-INJECTOR) MISFIRED¿. THE INVESTIGATION COMPLAINT SUB-TYPE BASED ON THE COMPLAINT INFORMATION WAS DETERMINED TO BE FOR MEDICINE LEFT IN SYRINGE AND LACK OF EFFECT. THE CMO PFIZER AND CPO PHILLIPS PERFORMED AN INVESTIGATION. G240611X (KC6010) EXP DEC 2025. PFIZER INVESTIGATION: INVESTIGATION ONGOING. PFIZER NOTIFIED ON (B)(6) 2024 TO EXPAND THE INVESTIGATION TO INCLUDE THIS LOT. THIS REPORT WILL BE AMENDED ONCE AMNEAL RECEIVES THE INVESTIGATION. THE CPO PHILLIPS PERFORMED AN INVESTIGATION FOR ¿MEDICINE LEFT IN SYRINGE¿ ON THE EPINEPHRINE AUTO-INJECTOR 0.3 MG LOT G240611X. AFTER REVIEW OF THE MANUFACTURING CONTROLS IN PLACE, PMM DOES NOT SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT (B)(4) AND THE MANUFACTURING PROCESS AT PMM. ALL IN-PROCESS TESTING MET ACCEPTABLE CRITERIA, THERE WERE NO DEVIATIONS OR DISCREPANCIES FOUND DURING ASSEMBLY OF THIS LOT THAT COULD HAVE LED TO THE DEFECT REPORTED BY THE CUSTOMER. ALL IN-PROCESS AND FINAL RELEASE CRITERIA WERE MET FOR THE LOT MANUFACTURED AT PHILLIPS-MEDISIZE. THERE WERE NO ADDITIONAL ANOMALIES NOTED AND THE LOT WAS ACCEPTABLE FOR RELEASE. THERE HAVE BEEN ZERO (0) OTHER COMPLAINTS REPORTED FOR LOT G240611X FOR THE PAST 24 MONTHS. THERE HAVE BEEN (B)(4) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY ¿MEDICINE LEFT IN SYRINGE¿ IN THE PAST 24 MONTHS. THE (B)(4) OTHER SIMILAR COMPLAINTS WERE INVESTIGATED, AND CONCLUDED THEY WERE NOT RELATED TO MANUFACTURING. THE REPORTED COMPLAINT WAS NOT CONFIRMED IN THE RETAIN SAMPLE REVIEW, THE RETAIN SAMPLE CONFORMED. G240305X (CPJT HP1557) EXP DEC 2025. THE CMO PFIZER PERFORMED AN INVESTIGATION FOR LACK OF EFFECT ON THE CPJT LOT HP1557. THE INVESTIGATION INCLUDED REVIEW OF THE INCOMING QUALITY AND MANUFACTURING BATCH RECORDS, DEVIATION INVESTIGATIONS, APRR REVIEW, AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE LACK OF EFFECT. THERE IS NO IMPACT ON PRODUCT QUALITY, REGULATORY COMPLIANCE, VALIDATION, STABILITY, OR PATIENT SAFETY. THERE IS NO IMPACT ON PRODUCT QUALITY. THE COMPLAINT SAMPLE WAS BY THE PC1 CUSTOMER ON (B)(6) 2023. THE COMPLAINT CONDITION WAS NOT CONFIRMED; THEREFORE, THE ROOT CAUSE CANNOT BE ATTRIBUTED TO MANUFACTURE OR VENDOR PROCESSES. THE ROOT CAUSE WAS NOT DETERMINED TO BE MANUFACTURE OR VENDOR RELATED AS INCOMING QUALITY COMPONENT TESTING, BULK RELEASE TESTING, AND CERTIFICATE OF ANALYSIS AT TIME OF RELEASE WERE ALL DETERMINED TO BE ACCEPTABLE. STORAGE CONDITIONS OR USER ERROR CANNOT BE RULED OUT AS THE ROOT CAUSE. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AS THE COMPLAINT CONDITION WAS NOT DETERMINED TO BE MANUFACTURER OR VENDOR RELATED. THE REPORTED DEFECT IS NOT REPRESENTATIVE OF THE QUALITY OF THE BATCH AND REMAINS ACCEPTABLE FOR FURTHER DISTRIBUTION. THE CPO PHILLIPS PERFORMED AN INVESTIGATION FOR MEDICINE LEFT IN SYRINGE ON THE EPINEPHRINE AUTO-INJECTOR 0.3 MG LOT G240305X. AFTER REVIEW OF THE MANUFACTURING CONTROLS IN PLACE, PMM DOES NOT SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT (B)(4) AND THE MANUFACTURING PROCESS AT PMM. ALL IN-PROCESS TESTING MET ACCEPTABLE CRITERIA, THERE WERE NO DEVIATIONS OR DISCREPANCIES FOUND DURING ASSEMBLY OF THIS LOT THAT COULD HAVE LED TO THE DEFECT REPORTED BY THE CUSTOMER. ALL IN-PROCESS AND FINAL RELEASE CRITERIA WERE MET FOR THE LOT MANUFACTURED AT PHILLIPS-MEDISIZE. THERE WERE NO ADDITIONAL ANOMALIES NOTED AND THE LOT WAS ACCEPTABLE FOR RELEASE. THERE HAVE BEEN ZERO (0) OTHER COMPLAINTS REPORTED FOR LOT G240305X FOR THE PAST 24 MONTHS. THERE HAVE BEEN (B)(4) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY MEDICINE LEFT IN SYRINGE IN THE PAST 24 MONTHS. THE (B)(4) OTHER SIMILAR COMPLAINTS WERE INVESTIGATED, AND CONCLUDED THEY WERE NOT RELATED TO MANUFACTURING. THE REPORTED COMPLAINT WAS NOT CONFIRMED IN THE RETAIN SAMPLE REVIEW, THE RETAIN SAMPLE CONFORMED. A REVIEW OF THE PFMEA WAS COMPLETED TO CONFIRM IF THE FAILURE MODE IS CAPTURED WITHIN THE CURRENT ASSEMBLY PROCESS. BASED ON THE INFORMATION PROVIDED FOR THE REPORTED COMPLAINT, MISFIRED, THE PATIENT STATED (B)(4) DEVICES HAD MISFIRED. THE INTAKE INFORMATION WAS REVIEWED, AND THE USER STATED, SHE HAD ADMINISTERED THE MEDICATION, AND IT WAS MISFIRED (MEDICATION DID NOT ADMINISTERED INTO BODY HOWEVER NEEDLE CAME OUT). THE CONCLUSION THAT THE DEVICE DID NOT WORK BASED THE AMOUNT OF FLUID LEFT IN THE GLASS CARTRIDGE? THIS QUESTION WAS ANSWERED YES PER THE QUESTIONNAIRE. BASED ON THIS INFORMATION THE USER MAY HAVE THOUGHT THEY DID NOT RECEIVE THE DOSE DUE TO THE SOLUTION REMAINING IN THE DEVICE. THE IFU STATES, EPINEPHRINE INJECTION, USP 0.3 MG AND EPINEPHRINE INJECTION, USP 0.15 MG EACH CONTAIN 1.1 ML OF EPINEPHRINE SOLUTION. 0.3 ML AND 0.15 ML EPINEPHRINE SOLUTION ARE DISPENSED FOR EPINEPHRINE INJECTION, USP 0.3 MG AND EPINEPHRINE INJECTION, USP 0.15 MG, RESPECTIVELY, WHEN ACTIVATED. THE SOLUTION REMAINING AFTER ACTIVATION IS NOT AVAILABLE FOR FUTURE USE AND SHOULD BE DISCARDED. THE INJECTION IS COMPLETE, AND YOU HAVE RECEIVED THE CORRECT DOSE OF THE MEDICATION IF YOU SEE THE NEEDLE STICKING OUT OF THE RED TIP. IF YOU DO NOT SEE THE NEEDLE REPEAT STEP 2. IN ADDITION, THE IFU STATES, EPINEPHRINE INJECTION IS A SINGLE-USE INJECTABLE DEVICE THAT DELIVERS A FIXED DOSE OF EPINEPHRINE. EPINEPHRINE INJECTION CANNOT BE REUSED. DO NOT ATTEMPT TO REUSE EPINEPHRINE INJECTION AFTER THE DEVICE HAS BEEN ACTIVATED. IT IS NORMAL FOR MOST OF THE MEDICINE TO REMAIN IN THE AUTO-INJECTOR AFTER THE DOSE IS INJECTED. THE CORRECT DOSE HAS BEEN ADMINISTERED IF YOU SEE THE NEEDLE STICKING OUT OF THE RED TIP. YOU MAY NEED TO USE A SECOND INJECTION IF SYMPTOMS CONTINUE OR RECUR. THE COMPLAINT SAMPLE WAS RETURNED ON 12 SEP 24 AND INSPECTED ON 12 SEP 24 FROM THE SAMPLE RETURN KIT PROVIDED BY IMPAX - AMNEAL. THREE (3) 0.3 MG AUTO-INJECTORS WERE RETURNED, WHICH INCLUDED SAMPLES FROM LOT G240305X EXP OCT 2025 (QTY (B)(4)) AND G240611X EXP DEC 2025. BASED ON THE COMPLAINT SAMPLE EVALUATION FOR THE REPORTED COMPLAINT OF "MISFIRED" WAS NOT CONFIRMED IN THE AS ALL DEVICES HAD BEEN FIRED, DELIVERED A DOSE AND WERE ADMINISTERED TO A PATIENT. EVIDENCE OF ALL DEVICES BEING FIRED AND DOSE DELIVERY WERE THE FOLLOWING; THE NEEDLE WAS PROJECTING FROM THE RED NOSE CAP, THE SPRING RELEASE TINES WERE NOT AFFIXED TO THE FIRING BUSHING, THE CARPUJECT HAD APPROXIMATELY 0.8 ML OF SOLUTION REMAINING AND THE DOSE ADJUSTMENT SCREW WAS IN CONTACT WITH THE STOP COLLAR. IN ADDITION, SKIN TISSUE RESIDUE WAS OBSERVED ON THE NEEDLE FOR ALL SAMPLES WHICH CONFIRMED THE DEVICE WAS ADMINISTERED TO THE PATIENT. AS SUCH THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS IDENTIFIED AS A CONFIRMED USER ERROR FOR THE REPORTED ¿MEDICINE LEFT IN SYRINGE AND LACK OF EFFECT, DUE TO NOT FOLLOWING THE IFU FOR CONFIRMATION OF DOSE DELIVERY FOR BOTH SUBJECT LOTS G240305X AND G240611X. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG LOT G240611X FOR THE COMPLAINT CATEGORY - MEDICINE LEFT IN THE SYRINGE AND LACK OF EFFECT, FOR THE REPORTED COMPLAINT CONFIRMED THE IN-PROCESS AND FINAL RELEASE CRITERIA WERE MET FOR THE LOT MANUFACTURED AT PHILLIPS. THE EVALUATION OF THE RETAIN SAMPLE CONFORMED AND MET SPECIFICATION. THE COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED COMPLAINT WAS NOT CONFIRMED FOR LOT G240611X AS THERE WAS EVIDENCE THAT THE DEVICE WAS ADMINISTERED TO THE PATIENT AND DELIVERED A DOSE. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS IDENTIFIED AS A CONFIRMED USER ERROR FOR THE REPORTED ¿MEDICINE LEFT IN SYRINGE AND LACK OF EFFECT, DUE TO NOT FOLLOWING THE IFU FOR CONFIRMATION OF DOSE DELIVERY. THERE WERE NO ISSUES RELATED TO THE MANUFACTURING PROCESS AT PHILIPS FOR LOT G240611X THAT WERE DETERMINED TO BE ATTRIBUTED TO THE REPORTED COMPLAINT. THE INVESTIGATION CONCLUDED LOT G240611X RELEASED TO MARKET WAS MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS AND SPECIFICATIONS. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG LOT G240305X FOR THE COMPLAINT CATEGORY ¿ MEDICINE LEFT IN THE SYRINGE AND LACK OF EFFECT, FOR THE REPORTED COMPLAINT CONFIRMED THE IN-PROCESS AND FINAL RELEASE CRITERIA WERE MET FOR THE LOT MANUFACTURED. THE EVALUATION OF THE RETAIN SAMPLE CONFORMED AND MET SPECIFICATION. THE DRUG PRODUCT FINAL RELEASE TESTING WAS REVIEWED AND MET SPECIFICATION AT THE TIME OF RELEASE. THE COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED COMPLAINT WAS NOT CONFIRMED FOR LOT G240305X AS THERE WAS EVIDENCE THAT THE DEVICE WAS ADMINISTERED TO THE PATIENT AND DELIVERED A DOSE. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS IDENTIFIED AS A CONFIRMED USER ERROR FOR THE REPORTED ¿MEDICINE LEFT IN SYRINGE AND LACK OF EFFECT, DUE TO NOT FOLLOWING THE IFU FOR CONFIRMATION OF DOSE DELIVERY. THERE WERE NO ISSUES RELATED TO THE MANUFACTURING PROCESS FOR LOT G240305X THAT WERE DETERMINED TO BE ATTRIBUTED TO THE REPORTED COMPLAINT. THE INVESTIGATION CONCLUDED LOT G240305X RELEASED TO MARKET WAS MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS AND SPECIFICATIONS. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE, AND DEVICE DELIVERY SYSTEM ISSUE WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO EMOTIONAL DISORDER AND SEIZURE WAS UNKNOWN. DE-CHALLENGE AND RE-CHALLENGE WERE ALSO UNKNOWN. THE OUTCOME OF THE EVENTS SEIZURE, DEVICE FAILURE, DEVICE DELIVERY SYSTEM ISSUE AND EMOTIONAL DISORDER WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF SEIZURE, DEVICE FAILURE, DEVICE DELIVERY SYSTEM ISSUE AND EMOTIONAL DISORDER WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS CASE HAS AEPQC ASSOCIATED. THE INVESTIGATION REPORT WAS ASSESSED NOT TO HAVE THE POSSIBILITY OF CAUSING ANY FUTURE HARM TO OTHER USERS OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1037634 | TWINJECT/ADRENACLICK | TYPE 2 | PQX | G240202X, G240305X, GT40611X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female | Other |