BD MAX¿ ENTERIC BACTERIAL PANEL

Description of Event or Problem

REPORT 1 OF 2. IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER PLEASE INCLUDE ACCESSION NUMBER, RUN#, SAMPLE POSITION, LOT# AND FINAL RESULTS REPORTED FOR EACH SAMPLE, IF APPLICABLE? ACCESSION #2324200356 RUN# 1411/1413 POSITION A2/A5 ENTERIC LOT# 3081377 EXTENDED LOT#3163333 INITIAL RESULT SALMON+ VIBRIO - REPEAT RESULT SALMON+ AND VIBRIO+ FINAL RESULT REPORTED SALMON+ VIBRIO - ACCESSION # 2324300520 RUN# 1415/1417 POSITION A1/A5&A6 ENTERIC LOT# 3081377 EXTENDED LOT# 3163333. INITIAL RESULT CAMPY+ SALMON+ REPEAT RESULT SALMON+ CAMPY- ON BOTH REPEATS FINAL RESULT REPORTED SALMON+ CAMPY- DISCREPANT RESULT.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY (REF. (B)(4) FROM LOTS 3081377 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY INDICATED THAT LOT 3081377 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT A PATIENT SAMPLE THAT GAVE A CAMPY POSITIVE RESULT ON THE INITIAL TEST BUT WAS NEGATIVE ON THE RETESTS. CUSTOMER PROVIDED RUNS FILE FOR THE INITIAL TEST (RUN #1415) AND FOR THE RETESTS (RUN #1417) FOR INVESTIGATION. THE PATIENT SAMPLE INITIALLY GAVE A CAMPY POSITIVE RESULT (POSITION A1, RUN 1415). THE CUSTOMER RETESTED THE SAMPLE TWO TIMES IN ANOTHER RUN (POSITION A5 AND A6, RUN 1417), USING TWO NEW SAMPLE PREPARATIONS, TO CONFIRM THIS RESULT. BOTH REPEAT SAMPLES RESULTED IN A NEGATIVE CAMPY RESULT (POSITION A5 AND A6, RUN 1417). MANUAL PCR CURVE ADJUDICATION OF THE CAMPY POSITIVE SAMPLES. PCR CURVES ANALYSIS OF SAMPLE A1 IN THE INITIAL TEST (RUN 1415) SHOWED ATYPICAL CURVES IN ALL CHANNELS, RESULTING IN A POSITIVE CAMPY TARGET RESULT. IT IS UNLIKELY THAT THIS ATYPICAL CURVE IS DUE TO TRUE AMPLIFICATION AND A ROOT CAUSE COULD NOT BE IDENTIFIED. THE REPEAT TEST SHOWED NO AMPLIFICATION, INDICATIVE OF A TRUE NEGATIVE SAMPLE (RUN 1417 POSITION A5 AND A6). IT MUST BE NOTED THAT MANUAL PCR CURVE ADJUDICATION AND VISUAL EXAMINATION OF ATYPICAL PCR CURVES IS A CONSERVATIVE ASSESSMENT OF THE DATA. THE ROOT CAUSE OF THE CAMPY POSITIVE CUSTOMER¿S RESULT WAS NOT IDENTIFIED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY LOT 3081377. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) SINCE NO NEW HAZARD WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

H3: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

REPORT 1 OF 2. IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. PLEASE INCLUDE ACCESSION NUMBER, RUN#, SAMPLE POSITION, LOT# AND FINAL RESULTS REPORTED FOR EACH SAMPLE, IF APPLICABLE? ACCESSION #(B)(6), RUN# 1411/1413 POSITION A2/A5 ENTERIC LOT# 3081377 EXTENDED LOT#3163333 INITIAL RESULT SALMON+ VIBRIO - REPEAT RESULT SALMON+ AND VIBRIO+ FINAL RESULT REPORTED SALMON+ VIBRIO - ACCESSION # (B)(6) RUN# 1415/1417 POSITION A1/A5&A6 ENTERIC LOT# 3081377 EXTENDED LOT# 3163333 INITIAL RESULT CAMPY+ SALMON+ REPEAT RESULT SALMON+ CAMPY- ON BOTH REPEATS FINAL RESULT REPORTED SALMON+ CAMPY-. DISCREPANT RESULT.