BD MAX¿ CTGCTV2

Additional Manufacturer Narrative

D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT (REF. 443906) LOT 5142287 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. THE REVIEW OF QUALITY CONTROL RECORDS OF BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT LOT 5142287 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. CUSTOMER REPORTED SMALL CURVES APPEARING IN THE 680/715 CHANNEL (NEISSERIA GONORRHOEAE, GC TARGET) WHEN THE PATIENT TESTS POSITIVE FOR TRICHOMONAS VAGINALIS (TV TARGET, 630/665 CHANNEL) WITH THE BD MAX¿ CTGCTV2 KIT. IN THESE SITUATIONS, THE GC TARGET IS NEGATIVE ON THE BD MAX¿ CTGCTV2 ASSAY. THE NEGATIVE GC TARGET WAS CONFIRMED BY SENDING THESES SAMPLE TO AN EXTERNAL LABORATORY (VIDRL). CUSTOMER PROVIDED FILES OF RUN 1629, 1652, 1656 AND 1734 FROM BD MAX¿ INSTRUMENT CT1039 FOR INVESTIGATION. DATA ANALYSIS IDENTIFIED FIVE OCCURRENCES MATCHING THE SITUATIONS DESCRIBED BY THE CUSTOMER ACROSS THE FOUR BD MAX¿ RUNS PROVIDED (SAMPLES B10/RUN 1629, B9/1652, A4 & A5/1656, AND A4/1734). MANUAL PCR CURVE ADJUDICATION OF THE GC TARGET FOR THESE FIVE RESULTS SHOWED NEGATIVE RESULTS. TO OBTAIN A GC POSITIVE RESULT, THE TARGET MUST BE DETECTED WITHIN VALID THRESHOLDS IN BOTH GC DETECTION CHANNELS (680/715 AND 530/565), AND THE POSITIVE OR NEGATIVE STATUS OF ALL BD MAX¿ CTGCTV2 TARGETS IS DETERMINED BASED ON A DYNAMIC ENDPOINT THRESHOLD, AS SPECIFIED IN THE BD CTGCTV2 FOR BD MAX¿ SYSTEM INSTRUCTIONS FOR USE. REVIEW OF THE FIVE SAMPLES CURVES INDICATED LOW AMPLIFICATIONS IN THE 680/715 CHANNEL AND THE AMPLIFICATIONS DID NOT MEET THE CHANNEL ASSAY THRESHOLD. MOREOVER, NO AMPLIFICATION WAS DETECTED IN THE 530/565 CHANNEL. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED ON BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT LOT 5142287. OVERALL, FOLLOWING INVESTIGATION, NO REAGENTS ISSUE IS SUSPECTED. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM A REAGENT ISSUE BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND A PREVENTIVE ACTION PLAN SINCE THERE IS NO INDICATION OF A PRODUCT ISSUE.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A TRICHOMONAS VAGINALIS (TV) FALSE POSITIVE PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. SAMPLE WAS SENT TO TO THE DEPARTMENT OF HEALTH FOR CONFIRMATION AND WAS TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.