BD CTGCTV2 FOR BD MAX¿ SYSTEM

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT (REF. (B)(4)) FROM LOT 4233979 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT DISCREPANT RESULTS FOR THE CHLAMYDIA TARGET, FOR ONE PATIENT SAMPLE. THE SAME SAMPLE BUFFER TUBE WAS USED TO PERFORM BOTH THE INITIAL AND THE REPEAT TESTS. CUSTOMER PROVIDED RUNS 2620 AND 2622 FROM BD MAX¿ INSTRUMENT CT2647 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION OF THE DISCREPANT SAMPLE REVEALED A LATE AND LOW AMPLIFICATION, BUT APPEARING TRUE, GENERATING A CHLAMYDIA POSITIVE RESULT FOR THE SAMPLE IN THE INITIAL TEST (RUN 2620, POSITION B4). NO AMPLIFICATION WAS VISIBLE IN THE REPEAT TEST (RUN 2622), WHEREAS INTERNAL CONTROL AMPLIFICATION CURVES OF BOTH TESTS WERE COMPARABLE WITHOUT ANOMALY. AS DESCRIBED IN THE INSTRUCTION FOR USE LOW LEVELS OF TARGET BELOW THE LIMIT OF DETECTION (LOD) OF THE ASSAY MAY BE DETECTED, BUT RESULTS MAY NOT BE REPRODUCIBLE. THIS COULD EXPLAIN THE CUSTOMER¿S DISCREPANCY. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. THE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION, ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT LOT 4233979. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION PLAN SINCE NO NEW HAZARD WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD CTGCTV2 FOR BD MAX¿ SYSTEM, A FALSE POSITIVE CHLAMYDIA TRACHOMATIS PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED AND GAVE A CHLAMYDIA TRACHOMATIS NEGATIVE RESULT. 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 CTGCTV2 FOR BD MAX¿ SYSTEM, A FALSE POSITIVE CHLAMYDIA TRACHOMATIS PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED AND GAVE A CHLAMYDIA TRACHOMATIS NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.