BD CTGCTV2 FOR BD MAX¿ SYSTEM (US

Description of Event or Problem

IT WAS REPORTED THAT BD CTGCTV2 FOR BD MAX¿ SYSTEM (US) RECEIVED POSITIVE ON A PATIENT SAMPLE AND AFTER REPEATING THEY RECEIVED A NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES HAVING A CT CHLAMYDIA TRACHOMATIS FALSE POSITIVE RESULT, ON A PATIENT SAMPLE PATIENT DOES NOT HAVE CLINICAL SYMPTOMS CONSISTENT WITH INFECTION. SO THEY REPEATED THE SAMPLE TEST AND THIS TIME WENT NEGATIVE. THE FIRST POSITIVE RESULT WAS REPORTED TO CLINICIANS. NO TREATMENT WAS GIVEN TO PATIENT DUE TO NOT HAVING SYMPTOMS.

Additional Manufacturer Narrative

A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX CTGCTV2 (REF. 443904) LOT 2151523 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX CTGCTV2 INDICATED THAT LOT 2151523 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT A PATIENT SAMPLE WHICH GAVE A POSITIVE RESULT FOR THE CT TARGET DURING INITIAL TEST BUT A NEGATIVE CT TARGET RESULT UPON REPEAT TEST, FROM THE SAME SBT. CUSTOMER PROVIDED RUN FILES FOR RUNS 477, 479, 480 AND 482 FROM BD MAX¿ CT2684 FOR INVESTIGATION AND IDENTIFIED SAMPLE IN POSITION A7 IN RUN 480 AS THE AFFECTED SAMPLE AND SAMPLE B11 IN RUN 482 AS THE REPEAT TEST. RUNS 477 AND 479 INCLUDED NEGATIVE CONTROL (SAMPLE B5 RUN 477) AND ENVIRONMENTAL MONITORING (SAMPLE B4 RUN 479) SAMPLES WITH EXPECTED NEGATIVE RESULTS, SUGGESTING THAT THE CUSTOMER¿S ISSUE MIGHT NOT BE LINKED TO ENVIRONMENTAL CONTAMINATION. RUNS 480 AND 482, CONCERNED BY THE CURRENT COMPLAINT FOR A DISCREPANT RESULT, WERE ANALYZED AND MANUAL PCR CURVE ADJUDICATION. PCR CURVES ANALYSIS OF SAMPLE A7 RUN 480 SHOW STEP DISLOCATIONS IN THE RAW PCR SIGNAL IN THE FAM, VIC, CY5 AND CY5.5 CHANNELS AND GENERATED POSITIVE RESULTS IN THE FAM CHANNEL (CT TARGET). THE POSITIVITY THRESHOLD WAS NOT REACHED IN THE OTHER CHANNELS. IT IS UNLIKELY THAT THE STEP DISLOCATIONS ARE DUE TO TRUE AMPLIFICATION AND NO ROOT CAUSE COULD BE IDENTIFIED. CURVES ANALYSIS OF SAMPLE B11 FROM RUN 482 (REPEAT TEST FROM THE SAME SBT) SHOW NO FLUORESCENCE DETECTION IN THE FAM CHANNEL (CT TARGET) NOR IN ANY OTHER CHANNEL. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR ABERRANT CURVE GEOMETRY IS A CONSERVATIVE ASSESSMENT OF THE DATA. OVERALL, BASED ON THE DATA ANALYZED, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX CTGCTV2 LOT 2151523. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED THAT BD CTGCTV2 FOR BD MAX¿ SYSTEM (US) RECEIVED POSITIVE ON A PATIENT SAMPLE AND AFTER REPEATING THEY RECEIVED A NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES HAVING A CT CHLAMYDIA TRACHOMATIS FALSE POSITIVE RESULT, ON A PATIENT SAMPLE PATIENT DOES NOT HAVE CLINICAL SYMPTOMS CONSISTENT WITH INFECTION. SO THEY REPEATED THE SAMPLE TEST AND THIS TIME WENT NEGATIVE. THE FIRST POSITIVE RESULT WAS REPORTED TO CLINICIANS. NO TREATMENT WAS GIVEN TO PATIENT DUE TO NOT HAVING SYMPTOMS.