BD MULTITEST¿

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD MULTITEST¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. COULD YOU PLEASE PROVIDE CONTAMINATION CHECKLIST? 2. COULD YOU PLEASE PROVIDE PATIENT SAMPLE CHECKLIST? 3. WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? 1. WERE SAMPLES CONTAMINATED? = SAMPLES WERE NOT CONTAMINATED. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE (GO TO QUESTION #3): 3. IF PATIENT SAMPLES WERE RE-DRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4.): 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): 5. PROVIDE DETAILS- HOW AND TO WHAT EXTENT? (GO TO QUESTION #6.): 6. WHAT IS THE CURRENT MEDICAL STATUS? (NO FURTHER QUESTIONS REQUIRED.): 1. YES. 2. UNKNOWN. 3. PATIENT SAMPLES WERE RE-TESTED USING A NEW VIAL OF REAGENT. SAMPLES WERE NOT RE-DRAWN. 4. NO. STAFF OPENED A NEW BOTTLE OF TBNK 6 COLOUR REAGENT YESTERDAY AND NOTED A STRANGE POPULATION THAT IS POSITIVE FOR ALL THE MARKERS IN ALL THE SAMPLES. THIS POPULATION DISAPPEARED AFTER RERUN THE SAMPLES WITH A NEW BOTTLE OF TBNK REAGENT OF THE SAME LOT. ATTACHED PLEASE FIND THE CONTAMINATED PLOTS AND THE REPEATS. BOTH TBNK BOTTLES (CAT# 644611) ARE THE SAME LOT 72236, EXP 31.05.2024. THE CONTAMINATED BOTTLE WAS THE 2ND BOTTLE OF 8 THAT ARRIVED ON 15.08.2023. THE 1ST BOTTLE(FINISHED) AND 3RD BOTTLE SEEMS OK AND WE STILL HAVE 5 UNOPENED BOTTLES OF THE SAME LOT.

Additional Manufacturer Narrative

E.1. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE CONTACT - FAHMY RAZAK G.1 - MANUFACTURING SITE CONTACT - FAHMY RAZAK G.1 - REPORTING OFFICE- BECTON DICKINSON AND COMPANY BD BIOSCIENCES H6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF CONTAMINATION OF TBNK REAGENT WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: - BATCH HISTORY RECORD (BHR) WAS REVIEWED AND MET SPECIFICATIONS PRIOR TO RELEASE. PRODUCT 644611 (BD MULTITEST 6-COLOR TBNK REAGENT, IVD) LOT 72236 PERFORMS AS INTENDED WITH NO PRODUCT FAILURE. - ROOT CAUSE DETERMINED CUSTOMER USER WAS USING UNCLEAN FLOW CYTOMETER INSTRUMENT WHICH CAUSED AND UNINTENDED USE ERROR AND NOT A PERFORMANCE ISSUE OF TBNK REAGENT. - INVESTIGATION FOUND BD APPLICATIONS SPECIALIST PROVIDED TROUBLESHOOTING ASSISTANCE TO CUSTOMER ON THIS CASE. IT WAS REPORTED THAT AFTER SPENDING SOME TIME WITH CUSTOMER IT WAS IDENTIFIED THE CONTAMINATION WAS FROM THE INSTRUMENT AND NOT TO THE TBNK REAGENT. AFTER CLEANING THE INSTRUMENT, THE CONTAMINATION DISAPPEARED AND THE TBNK REAGENT TESTING RESUMES TO NORMAL. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

LT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD MULTITEST¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. COULD YOU PLEASE PROVIDE CONTAMINATION CHECKLIST? 2. COULD YOU PLEASE PROVIDE PATIENT SAMPLE CHECKLIST? 3. WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? 1. WERE SAMPLES CONTAMINATED? = SAMPLES WERE NOT CONTAMINATED. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE (GO TO QUESTION #3): 3. IF PATIENT SAMPLES WERE RE-DRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4.): 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): 5. PROVIDE DETAILS- HOW AND TO WHAT EXTENT? (GO TO QUESTION #6.): 6. WHAT IS THE CURRENT MEDICAL STATUS? (NO FURTHER QUESTIONS REQUIRED.): 1. YES 2. UNKNOWN 3. PATIENT SAMPLES WERE RE-TESTED USING A NEW VIAL OF REAGENT. SAMPLES WERE NOT RE-DRAWN. 4. NO ============================================================================================= STAFF OPENED A NEW BOTTLE OF TBNK 6 COLOUR REAGENT YESTERDAY AND NOTED A STRANGE POPULATION THAT IS POSITIVE FOR ALL THE MARKERS IN ALL THE SAMPLES. THIS POPULATION DISAPPEARED AFTER RERUN THE SAMPLES WITH A NEW BOTTLE OF TBNK REAGENT OF THE SAME LOT. ATTACHED PLEASE FIND THE CONTAMINATED PLOTS AND THE REPEATS. BOTH TBNK BOTTLES (CAT# 644611) ARE THE SAME LOT 72236, EXP 31.05.2024. THE CONTAMINATED BOTTLE WAS THE 2ND BOTTLE OF 8 THAT ARRIVED ON 15.08.2023. THE 1ST BOTTLE(FINISHED) AND 3RD BOTTLE SEEMS OK AND WE STILL HAVE 5 UNOPENED BOTTLES OF THE SAME LOT.