BD MAX¿ CTGCTV2

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A DISCREPANT CHLAMYDIA TRACHOMATIS (CT) PATIENT RESULT WAS OBTAINED. SAMPLE INITIALLY TESTED CT POSITIVE. SAMPLE WAS THEN REPEATED AND WAS CT NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING BD COR¿ CTGCTV2 (REF. 443979) FROM KIT LOT 5237366 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. THE REVIEW OF QUALITY CONTROL RECORDS OF THE INDIVIDUAL COMPONENTS (MASTER MIX PLATES LOT 5224487, EXTRACTION PLATES LOT 5225443 AND LIQUID REAGENT PLATES LOT 5232273) INCLUDED IN BD COR¿ CTGCTV2 LOT 5237366 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. THE CUSTOMER REPORTED A DISCREPANT RESULT IN WHICH A SAMPLE INITIALLY TESTED POSITIVE FOR THE CHLAMYDIA TRACHOMATIS (CT) TARGET, WHEREAS REPEAT TESTING PRODUCED A NEGATIVE RESULT. CUSTOMER PROVIDED RUNS FROM 2026-FEB-23 AND 2026-FEB-24 FROM BD COR¿ INSTRUMENT CRM0115 FOR INVESTIGATION. THE SAMPLE SUSPECTED OF DISCREPANCY, WAS FOUND IN THE RUN COMPLETED ON 23-02-2026 13:08:27, IN POSITION BOTA01. THE SAME SAMPLE BUFFER TUBE WAS REPEATED IN THE RUN COMPLETED ON 24-02-2026 10:35:59, IN POSITION BOTA10. MANUAL PCR CURVES ADJUDICATION WAS DONE AND FOR THE FIRST TEST, THE AMPLIFICATION CURVE IN THE FAM CHANNEL (CT TARGET) REVEALED LATE AND LOW, BUT TRUE AMPLIFICATION WITHOUT ANY ANOMALY, WHEREAS THE REPEAT TEST SHOWED A FLAT CURVE, AGAIN WITHOUT ANOMALY. POSITIVE AND NEGATIVE CONTROLS INCLUDED IN THE REPEAT RUN COMPLETED ON FEBRUARY 24 PRESENTED AMPLIFICATION CURVES AS EXPECTED, SUGGESTING NO REAGENT ISSUE. MOREOVER, IN BOTH RUNS, THE INTERNAL CONTROL IN THE ROX CHANNEL SHOWED AMPLIFICATION VALUES AS EXPECTED, FURTHER SUPPORTING THAT NO REAGENT ISSUE OCCURRED. NEVERTHELESS, IT MUST BE NOTED THAT MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE DATA ANALYSIS AND INFORMATION PROVIDED, A SPECIMEN 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 RESULT IN THE INITIAL TEST. NONETHELESS, 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 ALL BD COR¿ CTGCTV2 COMPONENT LOTS USED BY THE CUSTOMER. THE ROOT CAUSE WAS NOT IDENTIFIED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION SINCE NO NEW HAZARD WAS IDENTIFIED.

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 MAX¿ CTGCTV2, A DISCREPANT CHLAMYDIA TRACHOMATIS (CT) PATIENT RESULT WAS OBTAINED. SAMPLE INITIALLY TESTED CT POSITIVE. SAMPLE WAS THEN REPEATED AND WAS CT NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.