ADRENACLICK
Report
- Report Number
- 3002919960-2025-00036
- Event Type
- Malfunction
- Date Received
- October 1, 2025
- Date of Event
- September 9, 2025
- Report Date
- October 8, 2025
- Manufacturer
- PHILLIPS-MEDISIZE LLC
- Product Code
- PQX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MEDICATION DID NOT INJECTED/MEDICATION WAS NOT DELIVERED [DEVICE DELIVERY SYSTEM ISSUE] NO ADVERSE EVENT. [NO ADVERSE EVENT] CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS DEVICE DELIVERY SYSTEM ISSUE AND NO ADVERSE EVENT IN A 33-YEAR-OLD FEMALE PATIENT (RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS 33 YEARS. ON 17-SEP-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA AN EMAIL AND A TELEPHONE CALL CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S ADRENACLICK (EPINEPHRINE AUTO-INJECTOR). ON (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR 0.3 MG (NDC: (B)(4), BATCH NO: G240906X, EXP DATE: 31-MAY-2026 AND SERIAL NUMBER: (B)(6) AS NEEDED VIA SUBCUTANEOUS ROUTE FOR ANAPHYLACTIC REACTION. CONCURRENT CONDITIONS INCLUDED ANAPHYLACTIC REACTION. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, ALLERGY, HISTORY OF PROCEDURES, SMOKING, ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE, AND LABORATORY TESTS WERE NOT REPORTED. ON (B)(6) 2025, THE PATIENT RECEIVED A SEALED MEDICATION BOX FROM PHARMACY AND STORED AT ROOM TEMPERATURE (71-73 DEGREE FAHRENHEIT). ON (B)(6) 2025, SHE EXPERIENCED A SEVERE ANAPHYLACTIC REACTION. AT THAT TIME THE PATIENT TRIED TO USE ONE OF THE AUTO-INJECTORS FROM THIS LOT, SHE PUSHED THE AUTO-INJECTOR AND NEEDLE POKED TO HER THIGH BUT MEDICATION WAS NOT DELIVERED AND AFTER THAT SHE CALLED TO 911 AND ADMITTED IN THE HOSPITAL AS AN EMERGENCY ADMIT ON THE SAME DAY (B)(6) 2025 AND CONFIRMED THAT SHE WAS HAVING ONE UNUSED EPIPEN. WHILE USING AUTO-INJECTO, THE PATIENT FIRST PULLED OFF SHEATH REMOVER CAP THEN SAFETY CAP PULLED OFF AND THEN SHE PLACED THE NOSE CAP ON THE OUTER THIGH AND HELD THE DEVICE AGAINST THE THIGH AFTER HEARING THE CLICK FOR THE REQUIRED COUNT TO 10. BUT THE PATIENT DIDN'T HEAR A CLICK ON THE DEVICE WHEN SHE PRESSED IT AGAINST HER BODY. THE REPORTER FURTHER STATED THAT, IN THE HOSPITAL THE NURSE AND THE PHYSICIAN ALSO CONFIRMED THAT MEDICATION WAS NOT DELIVERED TO THE CONSUMER, AS THEY OBSERVED THAT THE NEEDLE CAME OUTSIDE. IT WAS FURTHER REPORTED THAT, THE PATIENT DISCHARGED FROM THE HOSPITAL ON THE SAME DAY AND CONFIRMED THAT THE PATIENT STAYED JUST FOR TWO HOURS IN THE HOSPITAL AND SHE DIDN'T HAVE ANY INFORMATION ABOUT TREATMENT PROVIDED. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE DELIVERY SYSTEM ISSUE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE DELIVERY SYSTEM ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE CAUSALITY OF EVENTS DEVICE DELIVERY SYSTEM ISSUE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 01-OCT-2025. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. THIS INVESTIGATION WAS CONDUCTED IN ACCORDANCE WITH SOP 8.2004 COMPLAINTS/FEEDBACK. AFTER REVIEWING MANUFACTURING CONTROLS, PMM FOUND NO CORRELATION BETWEEN THE TECHNICAL COMPLAINT (B)(4) AND THE MANUFACTURING PROCESS AT PMM. FOR LOT G240906X, ALL IN-PROCESS TESTING ON 500 UNITS MET ACCEPTANCE CRITERIA, WITH NO DEVIATIONS OR DISCREPANCIES DURING ASSEMBLY THAT COULD EXPLAIN THE REPORTED DEFECT. ADDITIONALLY, 50 COMPOSITE UNITS PASSED ALL FINAL RELEASE CRITERIA BEFORE DISTRIBUTION. A REVIEW OF THE PFMEA CONFIRMED THAT THE FAILURE MODE ¿MEDICINE LEFT IN SYRINGE¿ IS NOT CAPTURED BECAUSE IT IS EXPECTED FOR SOME MEDICATION TO REMAIN IN THE AUTO-INJECTOR AFTER DOSE DELIVERY. THIS IS CONSISTENT WITH THE PATIENT INFORMATION AND INSTRUCTIONS FOR USE (PIL). PMM¿S REVIEW OF THE COMPLAINT FOUND THE ISSUE WAS NOT CONFIRMED BASED ON THE RETAINED SAMPLE INVESTIGATION. FURTHERMORE, THE COMPLAINT SAMPLE WAS NOT RETURNED TO AMNEAL FOR FURTHER ANALYSIS, PREVENTING CONFIRMATION OF THE COMPLAINT. THEREFORE, BASED ON COMPREHENSIVE TESTING, PROCESS REVIEW, AND THE NORMAL CHARACTERISTICS OF THE DEVICE, THERE IS NO EVIDENCE LINKING THE MANUFACTURING PROCESS TO THE DEFECT, AND THE COMPLAINT COULD NOT BE SUBSTANTIATED. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE DELIVERY SYSTEM ISSUE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE DELIVERY SYSTEM ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE CAUSALITY OF EVENTS DEVICE DELIVERY SYSTEM ISSUE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED 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.
MEDICATION DID NOT INJECTED/MEDICATION WAS NOT DELIVERED [DEVICE DELIVERY SYSTEM ISSUE] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS DEVICE DELIVERY SYSTEM ISSUE AND NO ADVERSE EVENT IN A 33-YEAR-OLD FEMALE PATIENT (RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS 33 YEARS. ON 17-SEP-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA AN EMAIL AND A TELEPHONE CALL CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S ADRENALIN (EPINEPHRINE AUTO-INJECTOR). ON (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR 0.3 MG (NDC: 0115-1694-49, BATCH NO: G240906X, EXP DATE: 31-MAY-2026 AND SERIAL NUMBER: (B)(6) AS NEEDED VIA SUBCUTANEOUS ROUTE FOR ANAPHYLACTIC REACTION. CONCURRENT CONDITIONS INCLUDED ANAPHYLACTIC REACTION. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, ALLERGY, HISTORY OF PROCEDURES, SMOKING, ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE, AND LABORATORY TESTS WERE NOT REPORTED. ON 15-JUL-2025, THE PATIENT RECEIVED A SEALED MEDICATION BOX FROM PHARMACY AND STORED AT ROOM TEMPERATURE (71-73 DEGREE FAHRENHEIT). ON 09-SEP-2025, SHE EXPERIENCED A SEVERE ANAPHYLACTIC REACTION. AT THAT TIME THE PATIENT TRIED TO USE ONE OF THE AUTO-INJECTORS FROM THIS LOT, SHE PUSHED THE AUTO-INJECTOR AND NEEDLE POKED TO HER THIGH BUT MEDICATION WAS NOT DELIVERED AND AFTER THAT SHE CALLED TO 911 AND ADMITTED IN THE HOSPITAL AS AN EMERGENCY ADMIT ON THE SAME DAY (B)(6) 2025 AND CONFIRMED THAT SHE WAS HAVING ONE UNUSED EPIPEN. WHILE USING AUTO-INJECTO, THE PATIENT FIRST PULLED OFF SHEATH REMOVER CAP THEN SAFETY CAP PULLED OFF AND THEN SHE PLACED THE NOSE CAP ON THE OUTER THIGH AND HELD THE DEVICE AGAINST THE THIGH AFTER HEARING THE CLICK FOR THE REQUIRED COUNT TO 10. BUT THE PATIENT DIDN'T HEAR A CLICK ON THE DEVICE WHEN SHE PRESSED IT AGAINST HER BODY. THE REPORTER FURTHER STATED THAT, IN THE HOSPITAL THE NURSE AND THE PHYSICIAN ALSO CONFIRMED THAT MEDICATION WAS NOT DELIVERED TO THE CONSUMER, AS THEY OBSERVED THAT THE NEEDLE CAME OUTSIDE. IT WAS FURTHER REPORTED THAT, THE PATIENT DISCHARGED FROM THE HOSPITAL ON THE SAME DAY AND CONFIRMED THAT THE PATIENT STAYED JUST FOR TWO HOURS IN THE HOSPITAL AND SHE DIDN'T HAVE ANY INFORMATION ABOUT TREATMENT PROVIDED. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE DELIVERY SYSTEM ISSUE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE DELIVERY SYSTEM ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE CAUSALITY OF EVENTS DEVICE DELIVERY SYSTEM ISSUE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1785868 | ADRENACLICK | TYPE 2 | PQX | PHILLIPS-MEDISIZE LLC | G240906X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female | Other |