BD CTGCTV2 FOR BD MAX¿ SYSTEM

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD (B)(6) FOR BD MAX¿ SYSTEM KIT (REF. (B)(4)) LOT 4325952 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT A SUSPECTED FALSE POSITIVE RESULT, WHICH WAS NEGATIVE WHEN TESTED WITH ANOTHER METHOD. REVIEW OF THE MANUFACTURING RECORDS OF THE BD (B)(6) FOR BD MAX¿ SYSTEM KIT LOT 4325952 INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED FILES OF RUN 3414 (PDF AND CSV) FROM INSTRUMENT (B)(6) FOR INVESTIGATION. MANUAL PCR CURVES ADJUDICATION WAS PERFORMED ON SAMPLE B6 WHICH WAS IDENTIFIED BY THE CUSTOMER AS THE AFFECTED SAMPLE. ANALYSIS REVEALED AN ATYPICAL CURVE WITHOUT SIGMOIDAL SHAPE IN THE CY5 CHANNEL WHEN LOOKING AT THE BACKGROUND SIGNAL, RESULTING IN A POSITIVE RESULT FOR THE TV TARGET. WHEN LOOKING AT THE RAW SIGNAL FOR THIS CHANNEL, AN ATYPICAL CURVE THAT DOES NOT SHOW ANY INCREASE IN FLUORESCENCE LEVEL IS OBSERVED. IT IS UNLIKELY THIS POSITIVE RESULT IS THE RESULT OF TRUE AMPLIFICATION. THE NEGATIVE REPEAT TEST FOR THIS SAMPLE, PERFORMED ON ANOTHER PLATFORM, SEEMS TO CORROBORATE THIS HYPOTHESIS. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR ABERRANT CURVE GEOMETRY IS A CONSERVATIVE ASSESSMENT OF THE DATA. 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 (B)(6) FOR BD MAX¿ SYSTEM KIT LOT 4325952. 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 TRENDS 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 TRICHOMONAS VAGINALIS (TV) FALSE POSITIVE PATIENT RESULT WITH UNUSUAL CURVES WAS OBTAINED. CLINICAL SYMPTOMS DID NOT MATCH TRICHOMONAS VAGINALIS POSITIVE RESULT. IN ADDITION, SPECIMEN WAS RETESTED ON GENEXPERT AND WAS TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD CTGCTV2 FOR BD MAX¿ SYSTEM, A TRICHOMONAS VAGINALIS (TV) FALSE POSITIVE PATIENT RESULT WITH UNUSUAL CURVES WAS OBTAINED. CLINICAL SYMPTOMS DID NOT MATCH TRICHOMONAS VAGINALIS POSITIVE RESULT. IN ADDITION, SPECIMEN WAS RETESTED ON GENEXPERT AND WAS TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

D.2B. 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.