TWINJECT/ADRENACLICK
Report
- Report Number
- 3002919960-2024-00031
- Event Type
- Malfunction
- Date Received
- August 2, 2024
- Date of Event
- July 20, 2024
- Report Date
- August 22, 2024
- Product Code
- PQX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
IT WAS JAMMED AND DID NOT WORK/ NEEDLE WOULD NOT RELEASE [DEVICE FAILURE] BLOOD PRESSURE WAS REALLY HIGH [BLOOD PRESSURE INCREASED] HEART RATE WAS EXTREMELY HIGH [HEART RATE INCREASED] WHOLE BODY WAS JUMPING [DYSKINESIA] THROAT WAS CLOSED [THROAT TIGHTNESS] CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE FAILURE, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT THIGHTNESS IN A 31-YEAR-OLD MALE PATIENT (RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS 31 YEARS. ON 22-JUL-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA AN EMAIL CONCERNING ABOVE-MENTIONED ADVERSE EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). ADDITIONAL SIGNIFICANT INFORMATION (#1) WAS RECEIVED ON 29-JUL-2024 FROM THE PATIENT VIA A EMAIL. NEW INFORMATION INCLUDED; REPORTER ADDRESS, PATIENT DETAILS (GENDER AGE, HEIGHT AND WEIGHT), PRODUCT DETAILS (START DATE, LOT NUMBER AND EXPIRY DATE), EVENT DEVICE FAILURE VERBATIM WAS UPDATED. ON (B)(6) 2024 THE PATIENT WAS BEING TREATED WITH EPINEPHRINE INJECTION (AUTO-INJECTOR) (BATCH/LOT: G240107X AND EXPIRATION DATE: JUN-2025) (DOSE, FREQUENCY, ROUTE, AND THERAPY DATES WERE NOT REPORTED) FOR ALLERGIC REACTION TO WASP. CONCURRENT CONDITIONS INCLUDED ALLERGIC REACTION TO WASP AND WASP STING. CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES/SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE WAS NOT REPORTED, AND THE LABORATORY TEST WERE BLOOD PRESSURE AND HEART RATE. IT WAS REPORTED THAT ON (B)(6) 2024 (2 WEEKS AGO) THE PATIENT WAS RECENTLY PRESCRIBED AN EPI PIN FOR THE ALLERGIC REACTION TO WASPS AND STUNG SIX TIMES BY YELLOW JACKETS. THE PATIENT WENT TO USE EPI PIN AND WOULD NOT WORK. THE PATIENT CONTACTED A LICENSED PARAMEDIC, AND HE TRIED GETTING IT TO WORK AND SAID IT WAS JAMMED. AFTER THAT THE AMBULANCE GOT AND THE PATIENT WAS ALMOST IN CARDIAC ARREST. THE PATIENT¿S HEART RATE WAS EXTREMELY HIGH AND BLOOD PRESSURE WAS REALLY HIGH AND WHOLE BODY WAS JUMPING AND THROAT WAS CLOSED. NOW THE PATIENT GOOD NOW AND SAFE. UPON FOLLOW-UP ON (B)(6) 2024, THE PATIENT TRIED TO USE EPI-PEN IN THIGH BIT NEEDLE WOULD NOT RELEASE CALLED THE FD MEMBERS PLAYED WITH IT FOR FIVE MINUTES AND MANUALLY GOT THE NEEDLE RELEASED AND STOCK ME BUT UNUSE IF MEDICINE WAS INJECTED. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT THIGHTNESS WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE FAILURE WAS UNKNOWN. THE OUTCOME OF THE EVENTS BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT THIGHTNESS WAS RESOLVED. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT THIGHTNESS WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
IT WAS JAMMED AND DID NOT WORK/ NEEDLE WOULD NOT RELEASE [DEVICE FAILURE]. BLOOD PRESSURE WAS REALLY HIGH [BLOOD PRESSURE INCREASED]. HEART RATE WAS EXTREMELY HIGH [HEART RATE INCREASED]. WHOLE BODY WAS JUMPING [DYSKINESIA]. THROAT WAS CLOSED [THROAT TIGHTNESS]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE FAILURE, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT TIGHTNESS IN A 31-YEAR-OLD MALE PATIENT (RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS 31 YEARS. ON (B)(6)2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA AN EMAIL CONCERNING ABOVE-MENTIONED ADVERSE EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). ADDITIONAL SIGNIFICANT INFORMATION (#1) WAS RECEIVED ON (B)(6) 2024 FROM THE PATIENT VIA A EMAIL. NEW INFORMATION INCLUDED; REPORTER ADDRESS, PATIENT DETAILS (GENDER AGE, HEIGHT AND WEIGHT), PRODUCT DETAILS (START DATE, LOT NUMBER AND EXPIRY DATE), EVENT DEVICE FAILURE VERBATIM WAS UPDATED. ON (B)(6) 2024 THE PATIENT WAS BEING TREATED WITH EPINEPHRINE INJECTION (AUTO-INJECTOR) (BATCH/LOT: G240107X AND EXPIRATION DATE: JUN-2025) (DOSE, FREQUENCY, ROUTE, AND THERAPY DATES WERE NOT REPORTED) FOR ALLERGIC REACTION TO WASP. CONCURRENT CONDITIONS INCLUDED ALLERGIC REACTION TO WASP AND WASP STING. CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES/SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE WAS NOT REPORTED, AND THE LABORATORY TEST WERE BLOOD PRESSURE AND HEART RATE. IT WAS REPORTED THAT ON (B)(6) 2024 (2 WEEKS AGO) THE PATIENT WAS RECENTLY PRESCRIBED AN EPI PIN FOR THE ALLERGIC REACTION TO WASPS AND STUNG SIX TIMES BY YELLOW JACKETS. THE PATIENT WENT TO USE EPI PIN AND WOULD NOT WORK. THE PATIENT CONTACTED A LICENSED PARAMEDIC, AND HE TRIED GETTING IT TO WORK AND SAID IT WAS JAMMED. AFTER THAT THE AMBULANCE GOT AND THE PATIENT WAS ALMOST IN CARDIAC ARREST. THE PATIENT¿S HEART RATE WAS EXTREMELY HIGH AND BLOOD PRESSURE WAS REALLY HIGH AND WHOLE BODY WAS JUMPING AND THROAT WAS CLOSED. NOW THE PATIENT GOOD NOW AND SAFE. UPON FOLLOW-UP ON (B)(6) 2024, THE PATIENT TRIED TO USE EPI-PEN IN THIGH BIT NEEDLE WOULD NOT RELEASE CALLED THE FD MEMBERS PLAYED WITH IT FOR FIVE MINUTES AND MANUALLY GOT THE NEEDLE RELEASED AND STOCK ME BUT UNUSE IF MEDICINE WAS INJECTED. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT TIGHTNESS WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE FAILURE WAS UNKNOWN. THE OUTCOME OF THE EVENTS BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT TIGHTNESS WAS RESOLVED. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT TIGHTNESS WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#2) INFORMATION RECEIVED ON 06-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 G240107X, ¿EPIPEN DID NOT WORK AND IT WAS JAMMED¿. 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 G240107X 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 G240107X FOR THE COMPLAINT CATEGORY ¿ FAILURE TO FIRE, FOR THE REPORTED COMPLAINT ¿EPIPEN DID NOT WORK AND IT WAS JAMMED¿ 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, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT TIGHTNESS WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE FAILURE WAS UNKNOWN. THE OUTCOME OF THE EVENTS BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT TIGHTNESS WAS RESOLVED. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT TIGHTNESS 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.
IT WAS JAMMED AND DID NOT WORK/ NEEDLE WOULD NOT RELEASE [DEVICE FAILURE]. BLOOD PRESSURE WAS REALLY HIGH [BLOOD PRESSURE INCREASED]. HEART RATE WAS EXTREMELY HIGH [HEART RATE INCREASED]. WHOLE BODY WAS JUMPING [DYSKINESIA]. THROAT WAS CLOSED [THROAT TIGHTNESS]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE FAILURE, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT THIGHTNESS IN A 31-YEAR-OLD MALE PATIENT (RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS 31 YEARS. ON 22-JUL-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA AN EMAIL CONCERNING ABOVE-MENTIONED ADVERSE EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). ADDITIONAL SIGNIFICANT INFORMATION (#1) WAS RECEIVED ON 29-JUL-2024 FROM THE PATIENT VIA A EMAIL. NEW INFORMATION INCLUDED; REPORTER ADDRESS, PATIENT DETAILS (GENDER AGE, HEIGHT AND WEIGHT), PRODUCT DETAILS (START DATE, LOT NUMBER AND EXPIRY DATE), EVENT DEVICE FAILURE VERBATIM WAS UPDATED. ON (B)(6) 2024 THE PATIENT WAS BEING TREATED WITH EPINEPHRINE INJECTION (AUTO-INJECTOR) (BATCH/LOT: G240107X AND EXPIRATION DATE: JUN-2025) (DOSE, FREQUENCY, ROUTE, AND THERAPY DATES WERE NOT REPORTED) FOR ALLERGIC REACTION TO WASP. CONCURRENT CONDITIONS INCLUDED ALLERGIC REACTION TO WASP AND WASP STING. CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES/SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE WAS NOT REPORTED, AND THE LABORATORY TEST WERE BLOOD PRESSURE AND HEART RATE. IT WAS REPORTED THAT ON (B)(6) 2024 (2 WEEKS AGO) THE PATIENT WAS RECENTLY PRESCRIBED AN EPI PIN FOR THE ALLERGIC REACTION TO WASPS AND STUNG SIX TIMES BY YELLOW JACKETS. THE PATIENT WENT TO USE EPI PIN AND WOULD NOT WORK. THE PATIENT CONTACTED A LICENSED PARAMEDIC, AND HE TRIED GETTING IT TO WORK AND SAID IT WAS JAMMED. AFTER THAT THE AMBULANCE GOT AND THE PATIENT WAS ALMOST IN CARDIAC ARREST. THE PATIENT¿S HEART RATE WAS EXTREMELY HIGH AND BLOOD PRESSURE WAS REALLY HIGH AND WHOLE BODY WAS JUMPING AND THROAT WAS CLOSED. NOW THE PATIENT GOOD NOW AND SAFE. UPON FOLLOW-UP ON 20-JUL-2024, THE PATIENT TRIED TO USE EPI-PEN IN THIGH BIT NEEDLE WOULD NOT RELEASE CALLED THE FD MEMBERS PLAYED WITH IT FOR FIVE MINUTES AND MANUALLY GOT THE NEEDLE RELEASED AND STOCK ME BUT UNUSE IF MEDICINE WAS INJECTED. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE FAILURE, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT THIGHTNESS WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE FAILURE WAS UNKNOWN. THE OUTCOME OF THE EVENTS BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT THIGHTNESS WAS RESOLVED. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT THIGHTNESS WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#2) INFORMATION RECEIVED ON 06-AUG-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON 22-JUL-2024, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT G240107X, ¿EPIPEN DID NOT WORK AND IT WAS JAMMED¿. 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 G240107X FOR THE PAST 24 MONTHS. THERE HAVE BEEN TWENTY-ONE (21) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY ¿FAILURE TO FIRE¿ IN THE PAST 24 MONTHS. NONE OF THE 21 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 G240107X FOR THE COMPLAINT CATEGORY ¿ FAILURE TO FIRE, FOR THE REPORTED COMPLAINT ¿EPIPEN DID NOT WORK AND IT WAS JAMMED¿ 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, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT THIGHTNESS WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE FAILURE WAS UNKNOWN. THE OUTCOME OF THE EVENTS BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT THIGHTNESS WAS RESOLVED. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT THIGHTNESS 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 (#3) INFORMATION RECEIVED ON 16-AUG-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON 22 JUL 2024, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT G240107X, ¿EPIPEN DID NOT WORK AND IT WAS JAMMED¿. 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 G240107X FOR THE PAST 24 MONTHS. THERE HAVE BEEN TWENTY-ONE (21) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY ¿FAILURE TO FIRE¿ IN THE PAST 24 MONTHS. NONE OF THE 21 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 RETURNED ON 14 AUG 24 AND INSPECTED ON 14 AUG 24 FROM THE SAMPLE RETURN KIT PROVIDED BY IMPAX - AMNEAL. ONE (1) 0.3 MG AUTO-INJECTOR WAS RETURNED, WHICH INCLUDED SAMPLES FROM LOT G240107X EXP JUN 2025. BASED ON THE COMPLAINT SAMPLE EVALUATION FOR THE REPORTED "EPIPEN DID NOT WORK AND IT WAS JAMMED" WAS NOT CONFIRMED AS THE DEVICE WAS RETURNED IN A FIRED STATE. EVIDENCE OF THE DEVICE 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 AND THE DOSE ADJUSTMENT SCREW WAS IN CONTACT WITH THE STOP COLLAR. IN ADDITION, SKIN RESIDUE OBSERVED ON THE NEEDLE CONFIRMED THE DEVICE WAS ADMINISTERED TO THE PATIENT. THERE WERE NO DEFECTS OBSERVED IN THE COMPLAINT SAMPLE EVALUATION THAT WOULD HAVE PREVENTED THE USER FROM ADMINISTERING THE DOSE. 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 THE COMPLAINT SAMPLE EVALUATION CONFIRMED THE DEVICE HAD BEEN FIRED AND ADMINISTERED TO THE PATIENT, A POTENTIAL ROOT CAUSE IS FAILURE TO FOLLOW THE INSTRUCTIONS FOR USE FOR ADMINISTRATION OF THE DOSE. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG; LOT G240107X FOR THE COMPLAINT CATEGORY ¿ FAILURE TO FIRE, FOR THE REPORTED COMPLAINT ¿EPIPEN DID NOT WORK AND IT WAS JAMMED¿ CONFIRMED THAT THE AUTO-INJECTORS WERE MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS. THE EVALUATION OF THE RETAIN SAMPLE CONFORMED AND MET SPECIFICATION. BASED ON THE COMPLAINT SAMPLE EVALUATION FOR THE REPORTED "EPIPEN DID NOT WORK AND IT WAS JAMMED" WAS NOT CONFIRMED AS THE DEVICE WAS RETURNED IN A FIRED STATE AND THERE WAS EVIDENCE THE DEVICE WAS ADMINISTERED TO THE PATIENT. 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, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT THIGHTNESS WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE FAILURE WAS UNKNOWN. THE OUTCOME OF THE EVENTS BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT THIGHTNESS WAS RESOLVED. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE FAILURE, BLOOD PRESSURE INCREASED, HEART RATE INCREASED, DYSKINESA AND THROAT THIGHTNESS 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 |
|---|---|---|---|---|---|---|---|
| 1037232 | TWINJECT/ADRENACLICK | TYPE 2 | PQX | G240107X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Male | Other| H |