BD MAX¿ CTGCTV2 (US)

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ CTGCTV2 US (REF (B)(4)) LOT 5098662 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 MAX¿ CTGCTV2 US LOT 5098662 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT (RUN 3415, POSITION B1) FOR CHLAMYDIA TRACHOMATIS (CT) AND TRICHOMONAS VAGINALIS (TV) TARGETS, AND UPON TESTING OF A NEW SAMPLE FROM THE SAME PATIENT, THE TEST RESULTED IN A NEGATIVE RESULT IN RUN 3418. BOTH THE ORIGINAL AND RECOLLECTED SAMPLES WERE THEN RETESTED IN RUN 3419 AND RESULTED IN A NEGATIVE RESULT. FINALLY, THE CUSTOMER PERFORMED ENVIRONMENTAL CONTROL IN RUN 3420, WHICH PRODUCED A NEGATIVE RESULT AS EXPECTED. ALL FOUR BD MAX¿ RUNS PROVIDED WERE ANALYZED. MANUAL ADJUDICATION OF THE PCR CURVES FOR THE INITIAL POSITIVE RESULT (RUN 3415 POSITION B1) REVEALED STEP DISLOCATIONS IN THE RAW AND BACKGROUND SIGNAL FOR THE CT TARGET (FAM CHANNEL) AND THE TV TARGET (CY5 CHANNEL). THESE STEP DISLOCATIONS LED TO A POSITIVE RESULT THAT DOES NOT APPEAR TO BE TRUE POSITIVE AMPLIFICATION. FURTHER ANALYSIS ALSO SHOWS SIMILAR STEP DISLOCATIONS IN THE RAW AND BACKGROUND SIGNALS OF THE CY5.5 AND VIC CHANNELS, ALTHOUGH THESE DID NOT CROSS THE THRESHOLD TO BE CONSIDERED POSITIVE. THIS SAMPLE WAS RETESTED IN RUN 3419, POSITION A3, AND GAVE A NEGATIVE TV AND CT RESULT, NO AMPLIFICATION OR ANOMALY WAS OBSERVED IN THESE CHANNELS NOR ANY OTHER CHANNEL. NEVERTHELESS, IT MUST BE NOTED THAT MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE INVESTIGATION, IT IS UNLIKELY THAT THE POSITIVE RESULT OF SAMPLE RUN 3415, POSITION B1, IS NOT INDICATIVE OF TRUE AMPLIFICATION. THE ROOT CAUSE WAS NOT IDENTIFIED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ CTGCTV2 US LOT 5098662. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND A PREVENTIVE ACTION PLAN SINCE NO NEW HAZARD WAS IDENTIFIED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A FALSE POSITIVE CHLAMYDIA AND TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. ORIGINAL PATIENT SAMPLE AND NEW COLLECTED PATIENT SAMPLE WERE THEN TESTED AND WERE BOTH TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A FALSE POSITIVE CHLAMYDIA AND TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. ORIGINAL PATIENT SAMPLE AND NEW COLLECTED PATIENT SAMPLE WERE THEN TESTED AND WERE BOTH TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.