BD MAX¿ CTGCTV2 (US)

Additional Manufacturer Narrative

D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY. THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT (REF. 443904) FROM LOT 5204477 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, 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 5204477 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. THE RETAIN MATERIAL OF BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT FROM LOT 5204477 WAS TESTED AND THE RESULTS WERE AS EXPECTED. CUSTOMER COMPLAINED ABOUT DISCREPANT RESULTS FOR CHLAMYDIA TRACHOMATIS (CT) TARGET WITH THE BD CTGCTV2 FOR BD MAX¿ SYSTEM, WHEN THE SAMPLE WAS INITIALLY NEGATIVE BUT TESTED POSITIVE UPON REPEAT TESTING. CUSTOMER PROVIDED THE DATABASE OF INSTRUMENT CT2473 FOR INVESTIGATION. ACCORDING TO THE CUSTOMER, THE DISCREPANT SAMPLE WAS FIRST TESTED IN RUN 2331, POSITION A12 AND THEN REPEATED WITH THE SAME SAMPLE BUFFER TUBE (SBT) IN RUN 2334, POSITION A4. MANUAL PCR CURVES ADJUDICATIONS WERE PERFORMED FOR THOSE TWO RUNS. THE FIRST TEST (RUN 2331/A12) WAS POSITIVE FOR THE TV TARGET AND NEGATIVE FOR THE CT TARGET ALTHOUGH A SLIGHT INCREASE IN RAW FLUORESCENCE IN THE FAM CHANNEL AT THE END OF THE RUN WAS OBSERVED, WHICH MAY SUGGEST THE PRESENCE OF CT TARGET DNA AT VERY LOW LEVELS. IN THE REPEAT TEST (RUN 2334/A4) THE AMPLIFICATION CURVE IN THE FAM CHANNEL (CT TARGET) SHOWED A LATE AMPLIFICATION, CONSISTENT WITH A LOW POSITIVE SAMPLE. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. 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 5204477. THE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), IS THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS. 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A DISCREPANT CHLAMYDIA TRACHOMATIS (CT) PATIENT RESULT WAS OBTAINED. ON THE FIRST RUN, CT WAS NEGATIVE, BUT UPON REPEAT THE CT RESULT WAS POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.