BD CTGCTV2 FOR BD MAX¿ SYSTEM

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. THE TEST WAS REPEATED AND GAVE A CHLAMYDIA TRACHOMATIS NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR A DISCREPANT RESULT WHEN USING THE BD MAX CTGCTV2 KIT (REF. 443904) LOT 4054266 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT OBTAINING A POSITIVE RESULT FOR THE CT TARGET THAT REPEATED NEGATIVE WHEN USING BD MAX¿ CTGCTV2 KIT LOT 4054266. REPEATS WERE PERFORMED FROM THE SAME SBT. REVIEW OF MANUFACTURING RECORDS OF THE BD MAX CTGCTV2 INDICATED THAT THE LOT 4054266 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUNS 3869, 3872, 3881 AND 3883 AND DATABASE FROM INSTRUMENT CT1273 FOR INVESTIGATION. CUSTOMER IDENTIFIED POSITIVE SAMPLES IN RUN 3869; POSITION A2 THAT REPEATED NEGATIVE IN RUN 3872; POSITION A1 AS TO BE INVESTIGATED. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE DISCREPANT SAMPLES. LATE AND LOW, BUT TRUE AMPLIFICATION OF THE CT TARGET IN THE FAM CHANNEL FOR THE ORIGINAL TEST. NO AMPLIFICATION IN THE FAM CHANNEL (CT TARGET) WAS OBSERVED FOR THE REPEAT TEST, AND A NEGATIVE RESULT IS THE EXPECTED RESULT IN SUCH CASES. 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 BD MAX CTGCTV2 LOT 4054266. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. HOWEVER, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION COULD EXPLAIN THE CUSTOMER¿S ISSUE. BD DID NOT INITIATE A CORRECTIVE AND A PREVENTIVE ACTION PLAN SINCE NO NEW HAZARD OR TRENDS WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY, QEP. 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. THE TEST WAS REPEATED AND GAVE A CHLAMYDIA TRACHOMATIS NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.