BD MAX¿ VAGINAL PANEL

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 WHILE USING THE BD MAX¿ VAGINAL PANEL THE CUSTOMER REQUESTED THRESHOLD RESULTS DUE TO DISCREPANT RESULTS. CUSTOMER NOTED THAT ON SEPTEMBER 26 A PATIENT WAS TESTED FOR MVP AND WAS POSITIVE BUT ONLY NEGATIVE FOR C.KRUSEI. ANOTHER SAMPLE FROM THE SAME PATIENT WAS TESTED ON SEPTEMBER 29 FOR CTGCTV AND THE RESULT WAS NEGATIVE. BOTH ASSAYS WERE TESTED ON THE SAME INSTRUMENT. PATIENT WAS UNTREATED AND THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REQUESTED FOR RESULTS THRESHOLD DUE TO DISCREPANT RESULTS. NOTED THAT ON 26 SEP MVP WAS TESTED FOR A PATIENT AND WAS POSITIVE ONLY NEG FOR C.KRUSEI. ANOTHER SAMPLE FROM THE SAME PATIENT WAS TESTED ON 09/29 ON CTGCTV (442970 LOT 2137538) AND WAS NEG. BOTH ASSAYS WERE TESTED ON THE SAME INSTRUMENT. BOTH SAMPLES ON BOTH RUNS CAME FROM SAME PATIENT 3 DAYS APART, AS PER PROVIDER SAME COLLECTION DONE AND PATIENT WAS UNTREATED.

Description of Event or Problem

CIT WAS REPORTED THAT WHILE USING THE BD MAX¿ VAGINAL PANEL THE CUSTOMER REQUESTED THRESHOLD RESULTS DUE TO DISCREPANT RESULTS. CUSTOMER NOTED THAT ON SEPTEMBER 26 A PATIENT WAS TESTED FOR MVP AND WAS POSITIVE BUT ONLY NEGATIVE FOR C.KRUSEI. ANOTHER SAMPLE FROM THE SAME PATIENT WAS TESTED ON SEPTEMBER 29 FOR CTGCTV AND THE RESULT WAS NEGATIVE. BOTH ASSAYS WERE TESTED ON THE SAME INSTRUMENT. PATIENT WAS UNTREATED AND THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REQUESTED FOR RESULTS THRESHOLD DUE TO DISCREPANT RESULTS. NOTED THAT ON 26 SEP MVP WAS TESTED FOR A PATIENT AND WAS POSITIVE ONLY NEG FOR C.KRUSEI. ANOTHER SAMPLE FROM THE SAME PATIENT WAS TESTED ON 09/29 ON CTGCTV (442970 LOT 2137538) AND WAS NEG. BOTH ASSAYS WERE TESTED ON THE SAME INSTRUMENT. BOTH SAMPLES ON BOTH RUNS CAME FROM SAME PATIENT 3 DAYS APART, AS PER PROVIDER SAME COLLECTION DONE AND PATIENT WAS UNTREATED.

Additional Manufacturer Narrative

H6 INVESTIGATION SUMMARY: COMPLAINT HISTORY REVIEW SHOWED NO OTHER COMPLAINT RECEIVED ON BD MAX¿ VAGINAL PANEL KIT LOT 2025609. IN THE LAST TWELVE MONTHS, COMPLAINT HISTORY REVIEW SHOWED SEVEN OTHER COMPLAINTS FOR FALSE POSITIVE OR DISCREPANT RESULTS WITH THE BD MAX¿ VAGINAL PANEL ASSAY. VARIOUS POTENTIAL ROOT CAUSES WERE IDENTIFIED SUCH AS ATYPICAL CURVES AND SAMPLES AT ASSAY LIMIT OF DETECTION (LOD). BASED ON THE COMPLAINT REVIEW, NO REAGENTS ISSUE WAS IDENTIFIED. BATCH HISTORY REVIEW WAS PERFORMED AND NO ANOMALY WAS OBSERVED, IN RECORDS OF BD MAX¿ VAGINAL PANEL REAGENT KIT LOT 2025609 WHICH COULD HAVE A LINK WITH THE CUSTOMER ISSUE. ALSO, THE KIT MET THE RELEASE SPECIFICATIONS AND QC RESULTS WERE WITHIN THE TRENDS. RETAIN MATERIAL WAS NOT TESTED SINCE IT WOULD NOT PROVIDE MORE INFORMATION THAN WHAT IS AVAILABLE FROM THE FINAL QC TEST. A GROSS PRODUCT CONTAMINATION WOULD HAVE BEEN DETECTED BY THE FINAL KIT QC TEST, WHICH IS NOT THE CASE. NO SAMPLE WAS RECEIVED FOR INVESTIGATION. THE TWO RUNS RECEIVED FOR INVESTIGATION WERE ANALYZED USING THE BANCS ALGORITHM SIMULATION SOFTWARE AND MANUAL PCR CURVE ADJUDICATION WAS PERFORMED. THE INITIAL TEST (RUN 778 LANE B7) SHOWED A STEP DISLOCATION IN ALL CHANNELS OF THE BOTTOM CARTRIDGE POSITION, GENERATING A CGROUP, CGLA AND TV POSITIVE RESULT. THE CURVES IN THE TOP CARTRIDGE POSITION SHOWED TRUE AMPLIFICATION WITH EARLY CT AND HIGH EP VALUES, SUGGESTING A TRUE BV POSITIVE RESULT, BUT THE TARGETS DETECTED IN THE BOTTOM POSITION DO NOT APPEAR TO BE TRUE AMPLIFICATION. WHEN RETESTED WITH BD MAX¿ CT/GC/TV ASSAY IN RUN 789 LANE A8, THERE WAS NO ISSUE OBSERVED IN THE CURVES AND THE SAMPLE WAS NEGATIVE FOR THE TV TARGET AS WELL AS FOR OTHER TARGETS IN THIS ASSAY. THE POSITIVE RESULTS FOR CGROUP, CGLA AND TV TARGETS FROM THE INITIAL TEST (RUN 778 LANE B7) ARE DUE TO ATYPICAL CURVES WHILE THE BV RESULT IS A TRUE POSITIVE RESULT. IT MUST BE NOTED THAT MANUAL PCR CURVES ADJUDICATION HAS LIMITATIONS AND THE RESULTING EVALUATION IS A CONSERVATIVE ASSESSMENT OF THE DATA. BD WAS UNABLE TO IDENTIFY THE CAUSE OF THESE STEP DISLOCATIONS WITH THE BD MAX¿ VAGINAL PANEL KIT. NEVERTHELESS, THE ISSUE APPEARS TO HAVE BEEN ISOLATED. H3 OTHER TEXT : SEE H.10.