KIT BD MAX CTGCTV2 US

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT (REF. 443904) LOT 3137830 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 CTGCTV2 FOR BD MAX¿ SYSTEM KIT INDICATED THAT LOT 3137830 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT CT AND TV POSITIVE RESULTS (RUN 1691/B1) ON A PATIENT SAMPLE, WHICH UPON REPEAT TWICE WITH SAME SBT (RUN 1699/B12) AND A NEW SBT (RUN 1697/B11) WERE NEGATIVES FOR ALL TARGETS. CUSTOMER PROVIDED RUN FILES 1691, 1697 AND 1699 FROM INSTRUMENT CT1483 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION OF THE CT AND TV POSITIVE RESULT IN THE INITIAL TEST (RUN 1691/B1) REVEALED A STEP DISLOCATION IN THE RAW PCR SIGNAL IN ALL CHANNELS, RESULTING IN A POSITIVE RESULT FOR CT AND TV TARGETS, SINCE THE SIGNAL CROSSED THE THRESHOLDS TO BE CONSIDERED POSITIVE. HOWEVER, IT IS UNLIKELY THAT THE STEP DISLOCATIONS ARE DUE TO TRUE AMPLIFICATION. THIS IS FURTHER SUPPORTED BY THE FACT THAT THE RETESTS, USING THE SAME AND A NEW SBT, SHOW NO AMPLIFICATION IN ANY CHANNEL. BD WAS UNABLE TO IDENTIFY A CAUSE FOR THE ATYPICAL PCR SIGNAL IN THE INITIAL TEST, BUT THIS SEEMED TO BE AN ISOLATED EVENT. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT LOT 3137830. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT BD MAX CTGCTV2 US, DISCREPANT RESULT OCCURRED. THIS IS A REPORT OF ONE OCCURRENCE, NO REPORT OF ADVERSE OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: PATIENT DISPUTED THEIR POS RESULT FOR CTGCTV2, AND THE REPEAT TESTS WERE NEG. CUSTOMER REQUESTED INVESTIGATION OF THE DISCREPANCY. FIRST REPEAT: 10/04/2023; NEW SBT FROM THE SAME SPECIMEN VIAL; RUN # 1697 IN B-11 - NEG; SECOND REPEAT: 10/05/2023; SAME (INITIAL) SBT; RUN # 1699 IN B12 - NEG; RESULT WAS INITIALLY REPORTED AS POS, AND LATER CORRECTED TO NEG. ALL RUNS DONE FROM THE SAME REAGENTS LOT # 3137830.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT BD MAX CTGCTV2 US, DISCREPANT RESULT OCCURRED. THIS IS A REPORT OF ONE OCCURRENCE, NO REPORT OF ADVERSE OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: PATIENT DISPUTED THEIR POS RESULT FOR CTGCTV2, AND THE REPEAT TESTS WERE NEG. CUSTOMER REQUESTED INVESTIGATION OF THE DISCREPANCY. FIRST REPEAT: (B)(6) 2023; NEW SBT FROM THE SAME SPECIMEN VIAL; RUN # 1697 IN B-11 - NEG; SECOND REPEAT: (B)(6) 2023; SAME (INITIAL) SBT; RUN # 1699 IN B12 - NEG; RESULT WAS INITIALLY REPORTED AS POS, AND LATER CORRECTED TO NEG. ALL RUNS DONE FROM THE SAME REAGENTS LOT # 3137830.

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. D.2. TWO ADDITIONAL CODES APPLY; MKZ, OUY.