BD MAX¿ VAGINAL PANEL

Additional Manufacturer Narrative

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1033588. D4: MEDICAL DEVICE EXPIRATION DATE: 1/4/2022. H4: DEVICE MANUFACTURE DATE: 2/2/2021. H6: INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX VAGINAL PANEL (REF 443712) LOT 1033588 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX VAGINAL PANEL INDICATED THAT LOT 1033588 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE RETAIN MATERIAL OF THE BD MAX VAGINAL PANEL FROM LOT 1033588 WAS TESTED AND THE RESULTS WERE AS EXPECTED WITH NORMAL AMPLIFICATION CURVES. CUSTOMER COMPLAINED ABOUT FOUR RESULTS (SAMPLES 6124, 0692, 3564 AND 3207) THAT WERE REPORTED NEGATIVE BY THE BD MAX VAGINAL PANEL ASSAY WHILE VARIOUS MICROORGANISMS (CANDIDA KRUSEI, GARDENERELLA VAGINALIS, CANDIDA ALBICANS) WERE IDENTIFIED BY CULTURE AND/OR MALDI-TOF. MOREOVER, ONE SAMPLE (0467) WAS REPORTED BV POSITIVE WITH THE BD MAX VAGINAL PANEL ASSAY WHEREAS ONLY LACTOBACILLUS WAS RECOVERED BY CULTURE. TWO RUN FILES WERE PROVIDED FOR THE ANALYSIS (RUNS 990 AND 991). MANUAL PCR CURVE ADJUDICATION OF THESE SAMPLES WERE PERFORMED. THE ANALYSIS REVEALED THAT SAMPLE 6124, IDENTIFIED BY MALDI-TOF AS CANDIDA KRUSEI, HAD NO AMPLIFICATION OF THE C. KRUSEI TARGET (CY5 CHANNEL) AND NO ANOMALY WAS OBSERVED IN THE RAW DATA CURVES. IT SUGGESTS THAT THE SAMPLE WAS AT THE ASSAY LIMIT OF DETECTION (LOD). ANALYSIS OF SAMPLE 0692, IDENTIFIED BY MALDI-TOF AS CANDIDA ALBICANS, HAD NO AMPLIFICATION OF THE C. ALBICANS TARGET (ROX CHANNEL) AND NO ANOMALY WAS OBSERVED IN THE RAW DATA CURVES. IT ALSO SUGGESTS THAT THE SAMPLE WAS AT THE LOD. AS FOR SAMPLES 3564 AND 3207, IDENTIFIED BY CULTURE AS GARDNERELLA VAGINALIS (GV), THE ANALYSIS REVEALED THAT A PCR AMPLIFICATION WAS OBSERVED FOR THE GV TARGET (CY5 CHANNEL), HOWEVER, CT VALUE WAS NOT HIGH ENOUGH TO BE REPORTED AS BV POSITIVE. THE BV ALGORITHM DETECTS BACTERIAL IMBALANCES (NOT ONLY THE PRESENCE OF GV) RESPONSIBLE FOR THE INFECTION AND THE VALUE OBTAINED FOR THE SAMPLE DID NOT PASS THE THRESHOLD REQUIRED, RESULTING IN A NEGATIVE RESULT. ANALYSIS OF SAMPLE 0467 REVEALED THAT THE PCR CURVES HAD AN AMPLIFICATION OF BOTH GARDNERELLA VAGINALIS AND MEGASPHAERA-1 TARGETS, WHICH WAS REPORTED AS BV POSITIVE. NO ANOMALY WAS OBSERVED IN THE RAW DATA CURVES. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BD MAX VAGINAL PANEL LOT 1033588. THE ROOT CAUSE WAS NOT IDENTIFIED. NOTE THAT SAMPLES AT THE LIMIT OF DETECTION OF THE ASSAY CAN CAUSE DISCREPANT RESULTS. ALSO, IT IS RECOMMENDED TO FOLLOW THE ¿RESULTS INTERPRETATION¿ SECTION OF THE PACKAGE INSERT FOR BV STATUS DETERMINATION. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING 5 BD MAX¿ VAGINAL PANELS FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A GRAM STAIN AS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " DISCREPANT RESULTS WITH BDMAX KIT. CULTURE FROM SAME SAMPLES WHERE IDENTIFY BY CONVENTIONAL METHOD (MALDI-TOF). "

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 5 BD MAX¿ VAGINAL PANELS FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A GRAM STAIN AS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " DISCREPANT RESULTS WITH BDMAX KIT. CULTURE FROM SAME SAMPLES WHERE IDENTIFY BY CONVENTIONAL METHOD (MALDI-TOF)."