Description of Event or Problem · 0
DID NOT FULLY RESOLVE THE ALLERGIC REACTION [DRUG EFFECT LESS THAN EXPECTED] IT LOOKS LIKE APPROX 1 ML IS STILL IN THE DEVICE [INCORRECT DOSE ADMINISTERED BY DEVICE]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DRUG EFFECT LESS THAN EXPECTED IN A PATIENT (AGE, GENDER, AND RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EXPERIENCE WAS NOT REPORTED. ON 18-JUL-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE OTHER HEALTHCARE PROFESSIONAL VIA AN EMAIL CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS BEING TREATED WITH EPINEPHRINE INJECTION (AUTO-INJECTOR) (NDC, SERIAL NUMBER, BATCH/LOT, EXPIRATION DATE, DOSE, FREQUENCY AND THERAPY DATES NOT REPORTED) FOR ALLERGIC REACTION. CONCURRENT CONDITION WAS INCLUDED AS ALLERGIC REACTION. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, MEDICAL HISTORY, HISTORY OF PROCEDURES/ SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING, ALCOHOL CONSUMPTION AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO A NON AMNEAL PRODUCT. EPINEPHRINE AUTO INJECTION WAS USED BUT DID NOT FULLY RESOLVE THE ALLERGIC REACTION. NURSE AND OFFICE NOT SURE IF THEY ADMINISTERED THE PRODUCT CORRECTLY MAY HAVE BEEN THE ISSUE. THE REPORTER WAS HAVING A TOUGH TIME USING THEM. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DRUG EFFECT LESS THAN EXPECTED WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DRUG EFFECT LESS THAN EXPECTED WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS DRUG EFFECT LESS THAN EXPECTED AS NOT REPORTED. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. FOLLOW-UP INFORMATION (#1 & 2) WAS RECEIVED ON 01-AUG-2024 AND 07-AUG-2024 RESPECTIVELY: SIGNIFICANT FOLLOW-UP INFORMATION (#1) WAS RECEIVED ON 01-AUG-2024 FROM NURSE VIA AN EMAIL. NEW INFORMATION INCLUDED ADDITIONAL REPORTER WAS ADDED, PATIENT DEMOGRAPHICS AND INITIALS WERE ADDED, SUSPECT DRUG LOT NO. EXPIRATION DATE WAS ADDED, ADDITIONAL EVENT INCORRECT DOSE ADMINISTERED BY DEVICE WAS ADDED. ADDITIONAL SIGNIFICANT INFORMATION (#2) WAS RECEIVED ON 07-AUG-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. THE PATIENT WAS BEING TREATED WITH EPINEPHRINE INJECTION 0.30 MG (AUTO-INJECTOR) (BATCH/LOT-6230907X, EXPIRATION DATE-APR-2025) VIA INTRAMUSCULAR ROUTE ON 18-JUL-2024 FOR ALLERGIC REACTION/ ANAPHYLACTIC REACTION. IT WAS REPORTED THAT AFTER ADMINISTRATION NEEDLE DID NOT RETRACT, NURSE WAS SEEING HOW TO SAFELY HANDLE THE PEN, LABEL HAD TO BE PEELED OFF THE PEN, WHICH WAS UNSAFE AFTER ADMINISTRATION IN AN EMERGENCY, PLACING STAFF AT RISK FOR CONTAMINATED NEEDLE STICK. IT WAS ALSO REPORTED THAT IT LOOKED LIKE APPROX. 1 ML WAS STILL IN THE DEVICE. ON 18-JUL-2024, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG LOT G230907X, ¿MEDICATION USED BUT DID NOT FULLY RESOLVE THE ALLERGIC REACTION¿. 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 HD7492. THE INVESTIGATION INCLUDED REVIEW OF THE INCOMING QUALITY AND MANUFACTURING BATCH RECORDS, DEVIATION INVESTIGATIONS, 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. THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MCPHERSON PLANT FOR EVALUATION. 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. 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 LOT HD7492 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 G230907X. 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. THERE HAVE BEEN ZERO (0) OTHER COMPLAINTS REPORTED FOR LOT G230907X FOR THE PAST 24 MONTHS. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY ¿MEDICINE LEFT IN THE SYRINGE¿ IN THE PAST 24 MONTHS. 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 USED BUT DID NOT FULLY RESOLVE THE ALLERGIC REACTION¿, THE PATIENT NEEDED A SECOND AUTO-INJECTOR ADMINISTERED TO FEEL THE EFFECT. THE QUESTIONNAIRE WAS REVIEWED, AND THE USER IDENTIFIED THAT THE NEED WAS VISIBLE AFTER INJECTION, HOWEVER THERE WAS CONCERN AS THERE WAS FLUID REMAINING INSIDE THE CPJT (DRUG PACKAGE SYRINGE) AND THE FIRST DOSE WASN¿T ADMINISTERED. THE IFU STATES, ¿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¿. AS SUCH THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS IDENTIFIED AS A POTENTIAL 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 COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION, AS SUCH THE COMPLAINT COULD NOT BE CONFIRMED. TO ADDRESS THE COMMENT THAT THE NEEDLE DID NOT RETRACT, THE DESIGN OF THE EPINEPHRINE AUTO-INJECTOR DOES NOT ALLOW FOR THE NEEDLE TO RETRACT. THE IFU STATES THAT THE NEEDLE STICKS OUT OF THE RED TIP AFTER INJECTION. THE LAST STEP AFTER GETTING EMERGENCY MEDICAL HELP, IS THE AFTER-USE DISPOSAL. THERE ARE CLEAR INSTRUCTIONS WITH PHOTOS TO CAREFULLY COVER THE NEEDLE WITH THE CARRYING CASE. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG LOT G230907X 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 NOT RETURNED, AS SUCH THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS IDENTIFIED AS A POTENTIAL 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 EPINEPHRINE IN RELATION TO DRUG EFFECT LESS THAN EXPECTED AND INCORRECT DOSE ADMINISTERED BY DEVICE WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DRUG EFFECT LESS THAN EXPECTED AND INCORRECT DOSE ADMINISTERED BY DEVICE WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS DRUG EFFECT LESS THAN EXPECTED AND INCORRECT DOSE ADMINISTERED BY DEVICE AS NOT REPORTED. 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.