BD MAX¿ ENTERIC BACTERIAL PANEL

Description of Event or Problem

IT WAS REPORTED THAT BD MAX¿ ENTERIC BACTERIAL PANEL POSITIVE PATIENT SAMPLE WAS NEGATIVE AFTER REPEAT TESTING. NO PATIENT TREATMENT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAMPLE # 1 WAS COLLECTED ON (B)(6) 2023, LIM BROTH INOCULATED, AND RAN WITH POS RESULT; THEN A NEW LIM BROTH WAS PREPARED FROM RAW STOOL KEPT AT 2-8 C, LIM BROTH INCUBATED FOR 24 HRS, RAN THE SAMPLE - NEG.

Additional Manufacturer Narrative

A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT BD MAX¿ ENTERIC BACTERIAL PANEL POSITIVE PATIENT SAMPLE WAS NEGATIVE AFTER REPEAT TESTING. NO PATIENT TREATMENT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAMPLE # 2 WAS COLLECTED ON (B)(6) 2023, RAN WITH POS RESULT; LAB'S POLICY IS TO REPEAT POS SAMPLES IF THEY WERE NEXT TO EACH OTHER TO EXCLUDE CROSS-CONTAMINATION; SAMPLE # 2 WAS NEG ON THE REPEAT.

Additional Manufacturer Narrative

THE FOLLOWING WERE UPDATED: MEDICAL DEVICE CATALOG #: 443812. MEDICAL DEVICE EXPIRATION DATE: 05/18/2024. MEDICAL DEVICE LOT # 2305513. DEVICE MANUFACTURE DATE: 11/16/2022.

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT (REF. (B)(4) LOT 2305513 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT INDICATED THAT LOT 2305513 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT TWO SAMPLES THAT GAVE VIBRIO POSITIVE RESULTS WHICH TESTED NEGATIVE WHEN REPEATED. CUSTOMER PROVIDED TWO RUNS FOR INVESTIGATION (RUNS 1726 AND 1729 FROM INSTRUMENT (B)(6). RUN #1726 CONTAINED TWO POSITIVE SAMPLES FOR THE VIBRIO TARGET CORRESPONDING TO THE CUSTOMER¿S DESCRIPTION OF THE ISSUE (SAMPLES IN POSITIONS A6 AND A5). MANUAL PCR CURVE ADJUDICATION WAS PERFORMED. ANALYSIS REVEALED THAT DESPITE THE FLUORESCENCE INCREASE OBSERVED IN THE BACKGROUND CORRECTED CURVES AT CYCLE 25 FOR THE TWO SAMPLES ANALYZED IN RUN 1726, THE SIGNAL IN THE ROX CHANNEL DOES NOT SHOW ANY AMPLIFICATION WHEN ANALYZED IN RAW, IN THE BOTTOM POSITION OF THE CARTRIDGE (VIBRIO TARGET), SUGGESTING THAT THE POSITIVE RESULTS ARE NOT THE RESULT OF TRUE AMPLIFICATION (DATA NOT SHOWN). A BD INSTRUMENT QUALITY ENGINEER ALSO REVIEWED THE CURVES AND CONFIRMED THAT THE VIBRIO POSITIVE RESULTS WERE POTENTIALLY CAUSED BY A NORMALIZER DRIFT ON INSTRUMENT (B)(6). AN INSTRUMENT SERVICE TICKET WAS OPENED TO FURTHER INVESTIGATE THIS ISSUE. BASED ON THE INVESTIGATION, THERE IS NO REAGENT ISSUE SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT LOT 2305513. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE REAGENT COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION PLAN (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.

Description of Event or Problem

IT WAS REPORTED THAT BD MAX¿ ENTERIC BACTERIAL PANEL POSITIVE PATIENT SAMPLE WAS NEGATIVE AFTER REPEAT TESTING. NO PATIENT TREATMENT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAMPLE # 1 WAS COLLECTED ON (B)(6) 2023, LIM BROTH INOCULATED, AND RAN WITH POS RESULT; THEN A NEW LIM BROTH WAS PREPARED FROM RAW STOOL KEPT AT 2-8 C, LIM BROTH INCUBATED FOR 24 HRS, RAN THE SAMPLE - NEG.