TWINJECT/ADRENACLICK
Report
- Report Number
- 3002919960-2024-00034
- Event Type
- Malfunction
- Date Received
- August 30, 2024
- Date of Event
- August 17, 2024
- Report Date
- September 17, 2024
- Product Code
- PQX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
INJECTED NEEDLE TO THE THIGH AND NOTICED THAT MEDIATION DID NOT ADMINISTER INSIDE THE BODY [DEVICE MALFUNCTION] PATIENT STATED THAT MEDICATION DID NOT WORK FOR HIM. [DRUG INEFFECTIVE] CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE MALFUNCTION AND DRUG INEFFECTIVE IN A 20-YEAR-OLD MALE WHITE PATIENT FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EXPERIENCE WAS 20 YEARS. ON 20-AUG-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PHARMACIST AND PATIENT'S MOTHER VIA A VOICEMAIL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE INJECTION, AUTO-INJECTOR). ON AN UNKNOWN DATE, THE PATIENT WAS USING TWINJECT 0.3 (EPINEPHRINE INJECTION, AUTO-INJECTOR) (BATCH/LOT: G231103X AND EXPIRATION DATE: JUN-2025, NDC-0115-1694-49) (ROUTE, AND THERAPY DATES WERE NOT REPORTED) ON (B)(6) 2024 FOR ANAPHYLACTIC REACTION. CURRENT CONDITION INCLUDED ANAPHYLACTIC REACTION. HISTORY OF ALLERGIES INCLUDED PEANUTS AND TREENUTS ALLERGY. PATIENT DID NOT HAVE ANY MEDICAL HISTORY. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, CONCURRENT CONDITION, HISTORY OF PROCEDURES/ SURGERIES, HISTORY OF SMOKING, ALCOHOL CONSUMPTION, AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. ON (B)(6) 2024, THE AUTO-INJECTION WAS PURCHASED AND ON (B)(6) 2024 AT NIGHT, PATIENT ATE THE FOOD WHICH HAS PEANUTS AND ON (B)(6) 2024 HE EXPERIENCED ALLERGIC REACTION, AND HE INJECTED NEEDLE TO THE THIGH, HE NOTICED THAT MEDIATION DID NOT ADMINISTER INSIDE THE BODY. HE GOT TO KNOW THROUGH THE VIEWING WINDOW AS MEDICATION IS STILL IN THE DEVICE. HE WENT EMERGENCY VISIT TO THE HOSPITAL AND AFTER FEW HOURS HE GOT DISCHARGED IN HOSPITAL HE GOT TREATED WITH SECOND EPIPEN INJECTION FOR ALLERGIC REACTION AND IT WORKED, STEROIDS, BENADRYL, SALINE. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE MALFUNCTION AND DRUG INEFFECTIVE WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE MALFUNCTION AND DRUG INEFFECTIVE WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE MALFUNCTION AND DRUG INEFFECTIVE WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. SIGNIFICANT FOLLOW UP INFORMATION (#1) AND FOLLOW UP INFORMATION (#2) WERE RECEIVED ON 09-SEP-2024 AND 10-SEP-2024 RESPECTIVELY: FOLLOW UP INFORMATION (#1) WAS RECEIVED FROM THE PHARMACIST VIA A TELEPHONE CALL. NEW INFORMATION INCLUDED; PRODUCT DETAILS (EXP DATE UPDATED FROM JUN-2025 TO JUN-2026) AND NARRATIVE UPDATED. FOLLOW UP INFORMATION (#2) WAS RECEIVED FROM QA TEAM INCLUDES INVESTIGATION REPORT. THE PATIENT WAS BEING TREATED WITH TWINJECT 0.3 (EXP DATE: JUN-2026) ON 17-AUG-2024 FOR ANAPHYLACTIC REACTION. ON 20 AUG 2024, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG LOT G231103X, ¿MEDICATION DID NOT WORK¿. 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 AND INVESTIGATION. THE CMO PFIZER PERFORMED AN INVESTIGATION FOR ¿LACK OF EFFECT¿ ON THE CPJT LOT HH2973. THE COMPLAINT FOR LACK OF EFFECT IN A CARTRIDGE OF EPINEPHRINE PRODUCT LOT HH2973, FILL LOT HH1472 WAS INVESTIGATED. 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. THIS PRODUCT IS RECEIVED IN AS API, COMPOUNDED, MANUFACTURED, BULK PACKAGED BY PFIZER MCPHERSON AND SHIPPED TO THE PC1 CUSTOMER FOR ADDITIONAL INSPECTION AND PROCESSING. 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. THE COMPLAINT SAMPLE WAS EVALUATED BY THE PC1 CUSTOMER ON 03SEP2023. THE COMPLAINT CONDITION WAS NOT CONFIRMED; THEREFORE, THE ROOT CAUSE CANNOT BE ATTRIBUTED TO MANUFACTURE OR VENDOR PROCESSES. THE COMPLAINT DATABASE WAS REVIEWED FOR COMPLAINTS AGAINST LOT HH2973. THE CURRENT RECORD IS THE 1ST COMPLAINT AGAINST THE LOT. A COMPLAINT LOT TREND WAS NOT IDENTIFIED FOR THE LOT. 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 G231103X. AFTER REVIEW OF THE MANUFACTURING CONTROLS IN PLACE, PMM DOES NOT SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT COMP_2024_4094 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 ZERO (0) OTHER COMPLAINTS REPORTED FOR LOT G231103X FOR THE PAST 24 MONTHS. THERE HAS BEEN 01 OTHER, SIMILAR COMPLAINT REPORTED IN THE COMPLAINT CATEGORY ¿MEDICINE LEFT IN SYRINGE¿ IN THE PAST 24 MONTHS. THE 1 OTHER SIMILAR COMPLAINT WAS INVESTIGATED, AND IT WAS CONCLUDED THAT IT WAS NOT RELATED TO MANUFACTURING. THE REPORTED COMPLAINT WAS NOT CONFIRMED IN THE RETAIN SAMPLE REVIEW, THE RETAIN SAMPLE CONFORMED. BASED ON THE INFORMATION PROVIDED FOR THE REPORTED COMPLAINT, ¿MEDICATION DID NOT WORK¿, THE PATIENT NEEDED A SECOND AUTO-INJECTOR ADMINISTERED TO FEEL THE EFFECT. THE INTAKE INFORMATION WAS REVIEWED, AND THE USER IDENTIFIED THEY INJECTED NEEDLE TO THE THIGH, BUT NOTICED THAT MEDIATION DID NOT ADMINISTER INSIDE THE BODY. HE GOT TO KNOW THROUGH THE VIEWING WINDOW AS MEDICATION IS STILL IN THE DEVICE. IN ADDITION PER THE QUESTIONNAIRE QUESTIONS; IF THE NEEDLE IS EXPOSED AND YOU NOTICE LIQUID STILL IN THE DEVICE, DO YOU KNOW THAT THIS IS NORMAL, THAT NOT ALL THE LIQUID IS DELIVERED WHEN THE DOSE IS ADMINISTERED? THE QUESTION WAS ANSWERED ¿YES¿ (NOTICED LIQUID STILL IN THE DEVICE). WAS THE CONCLUSION THAT THE DEVICE DID NOT WORK BASED THE AMOUNT OF FLUID LEFT IN THE GLASS CARTRIDGE? THE QUESTION WAS ANSWERED ¿YES¿. BASED ON THIS INFORMATION THE USER MAY HAVE THOUGH 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 23 AUG 24 FROM THE SAMPLE RETURN KIT PROVIDED BY IMPAX - AMNEAL. TWO (2) 0.3 MG AUTO-INJECTORS WERE RETURNED, WHICH INCLUDED SAMPLES FROM LOT G221103X EXP JUN 2025. BASED ON THE COMPLAINT SAMPLE EVALUATION FOR THE REPORTED COMPLAINT OF "MEDICATION DID NOT WORK" WAS NOT CONFIRMED IN THE AS BOTH DEVICES HAD BEEN FIRED, DELIVERED A DOSE AND WERE ADMINISTERED TO A PATIENT. EVIDENCE OF BOTH 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. TO NOTE THE CARPUJECT (DRUG PACKAGE) IS FILED TO 1.1ML OF SOLUTION, WHEN DOSE IS DELIVERED ONLY 0.3ML OF SOLUTION IS DISPENSED, LEAVING 0.8ML OF SOLUTION REMAINING IN THE DEVICE. IN ADDITION, BLOOD AND/OR SKIN TISSUE RESIDUE WAS OBSERVED ON THE NEEDLES 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. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG LOT G231103X 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 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 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 MALFUNCTION AND DRUG INEFFECTIVE WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE MALFUNCTION AND DRUG INEFFECTIVE WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE MALFUNCTION AND DRUG INEFFECTIVE WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS CASE HAS AEPQC COMPLAINT ASSOCIATED. THE INVESTIGATION REPORT WAS ASSESSED NOT TO HAVE THE POSSIBILITY OF CAUSING ANY FUTURE HARM TO OTHER USERS OF THE PRODUCT.
INJECTED NEEDLE TO THE THIGH AND NOTICED THAT MEDIATION DID NOT ADMINISTER INSIDE THE BODY [DEVICE MALFUNCTION]. PATIENT STATED THAT MEDICATION DID NOT WORK FOR HIM. [DRUG INEFFECTIVE]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE MALFUNCTION AND DRUG INEFFECTIVE IN A 20-YEAR-OLD MALE WHITE PATIENT FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EXPERIENCE WAS 20 YEARS. ON 20-AUG-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PHARMACIST AND PATIENT'S MOTHER VIA A VOICEMAIL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE INJECTION, AUTO-INJECTOR). ON AN UNKNOWN DATE, THE PATIENT WAS USING TWINJECT 0.3 (EPINEPHRINE INJECTION, AUTO-INJECTOR) (BATCH/LOT: G231103X AND EXPIRATION DATE: JUN-2025, NDC-0115-1694-49) (ROUTE, AND THERAPY DATES WERE NOT REPORTED) ON (B)(6) 2024 FOR ANAPHYLACTIC REACTION. CURRENT CONDITION INCLUDED ANAPHYLACTIC REACTION. HISTORY OF ALLERGIES INCLUDED PEANUTS AND TREENUTS ALLERGY. PATIENT DID NOT HAVE ANY MEDICAL HISTORY. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, CONCURRENT CONDITION, HISTORY OF PROCEDURES/ SURGERIES, HISTORY OF SMOKING, ALCOHOL CONSUMPTION, AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. ON (B)(6) 2024, THE AUTO-INJECTION WAS PURCHASED AND ON (B)(6) 2024 AT NIGHT, PATIENT ATE THE FOOD WHICH HAS PEANUTS AND ON (B)(6) 2024 HE EXPERIENCED ALLERGIC REACTION, AND HE INJECTED NEEDLE TO THE THIGH, HE NOTICED THAT MEDIATION DID NOT ADMINISTER INSIDE THE BODY. HE GOT TO KNOW THROUGH THE VIEWING WINDOW AS MEDICATION IS STILL IN THE DEVICE. HE WENT EMERGENCY VISIT TO THE HOSPITAL AND AFTER FEW HOURS HE GOT DISCHARGED IN HOSPITAL HE GOT TREATED WITH SECOND EPIPEN INJECTION FOR ALLERGIC REACTION AND IT WORKED, STEROIDS, BENADRYL, SALINE. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE MALFUNCTION AND DRUG INEFFECTIVE WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE MALFUNCTION AND DRUG INEFFECTIVE WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE MALFUNCTION AND DRUG INEFFECTIVE WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1912480 | TWINJECT/ADRENACLICK | TYPE 2 | PQX | G231103X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Male | Other |