BD MAX¿ VAGINAL PANEL

Description of Event or Problem

IT WAS REPORTED THAT WHILE TESTING WITH THE BD MAX¿ VAGINAL PANEL, AN UNSPECIFIED NUMBER OF SAMPLES WERE FALSE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX VAGINAL PANEL KIT (REF. 443712) KIT LOT 3353975 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA, RETAIN MATERIAL TESTING AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT A NEGATIVE RESULT ON FOR THE BV TARGETS WHEN TESTING A POSITIVE CONTROL USING THE BD MAX VAGINAL PANEL KIT LOT 3353975. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX VAGINAL PANEL KIT INDICATED THAT LOT 3353975 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUNS 17 AND 18 PERFORMED ON BD MAX INSTRUMENT CT3312 THAT WERE ANALYZED. WHEN TESTING A POOL OF POSITIVE CONTROLS, ONE OF THE MULTIPLE REPEATS GAVE A NEGATIVE RESULT FOR THE BV TARGETS. ANALYSIS SHOWED THAT CUSTOMER TESTED MULTIPLE REPLICATES OF 5 DIFFERENT POOLS. ALL FIVE POOLS GAVE EXPECTED RESULTS ACROSS REPLICATES WITH THE EXCEPTION OF ONE OF THE 8 REPLICATES OF POOL #3 FOUND IN RUN 17; POSITION B2. THIS SAMPLE GAVE AN UNEXPECTED NEGATIVE RESULT FOR ALL BV TARGETS (TOP POSITION) WHEREAS AN EXPECTED POSITIVE RESULT WAS OBTAINED FOR THE CGROUP TARGET (BOTTOM POSITION). THIS SAMPLE RESULTS WERE ANALYZED AND MANUAL PCR CURVES ADJUDICATION WAS PERFORMED FOR THIS SPECIFIC SAMPLE. THE ANALYSIS REVEALED LATE AMPLIFICATION FOR TWO BV TARGETS (GARDNERELLA VAGINALIS AND MEGASPHAERA-1). THE AMPLIFICATION OF THESE 2 TARGETS IS NOT SUFFICIENT TO MEET THE CRITERIA TO BE CONSIDERED AS BV POSITIVE BY THE ALGORITHM AND THE SPC IN TOP POSITION OF THE CARTRIDGE FOR THIS SAMPLE SHOWED VERY LOW AMPLIFICATION. IN BOTTOM POSITION OF THE CARTRIDGE, THE CORRESPONDING CURVES SHOWED EXPECTED AMPLIFICATION OF THE CGROUP AND SPC TARGETS. SINCE THE BD MAX VAGINAL PANEL ALGORITHM CONSIDERS ONLY THE SPC AMPLIFICATION IN THE BOTTOM POSITION OF THE CARTRIDGE, THE RESULT WAS INTERPRETED AS VALID BY THE ALGORITHM. CONSIDERING THAT, IN TOP POSITION OF THE CARTRIDGE, THE SPC SHOWED ALMOST NO AMPLIFICATION, COMBINED WITH THE FACT THAT IN THIS SPECIFIC REPLICATE OF THE SAMPLE SOME TARGETS SHOWED LATE AMPLIFICATION, SUGGESTS THAT THE ISSUE IS NOT LINKED TO THE REAGENTS. MOREOVER, IT APPEARS TO BE THE ONLY OCCURRENCE FOR UNEXPECTED NEGATIVE RESULT IN ALL THE RUNS PERFORMED WITH THIS LOT. THE RETAIN MATERIAL OF BD MAX VAGINAL PANEL KIT FROM LOT 3353975 WAS TESTED AND THE RESULTS WERE AS EXPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX VAGINAL PANEL KIT LOT 3353975. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION SINCE NO NEW HAZARD OR TRENDS WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE TESTING WITH THE BD MAX¿ VAGINAL PANEL, AN UNSPECIFIED NUMBER OF SAMPLES WERE FALSE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

D2. ADDITIONAL MEDICAL DEVICE TYPES: NSU, OUY, PQA. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.