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¿ (REF. (B)(4)) LOT 3005986 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¿ PRODUCT INDICATED THAT LOT 3005986 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE CUSTOMER REPORTED DISCREPANT CT RESULTS ON TWO SAMPLES WITH THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT FROM LOT 3005986. THE SAMPLES GAVE A POSITIVE RESULT FOR THE CT TARGET BUT WHEN REPEATED FROM THE SAME SBT, THEY GAVE A NEGATIVE RESULT. THE CORRESPONDING RUNS (RUNS 777, 780, 781 AND 783 FROM CT2684) WERE ANALYZED. PCR CURVE ADJUDICATION WAS DONE FOR SAMPLE FROM RUN 777 POSITION A8 AND SAMPLE FROM RUN 780 POSITION A3. H.6. INVESTIGATION SUMMARY: THEY GAVE A CT POSITIVE RESULT, BUT ANALYSIS OF THE RAW PCR CURVES IN FAM SHOWED A STEP DISLOCATION, RESULTING IN A POSITIVE RESULT FOR THE CT TARGET. IT IS UNLIKELY THAT THESE POSITIVE RESULTS ARE TRUE AMPLIFICATIONS AND NO ROOT CAUSE COULD BE IDENTIFIED. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR ABERRANT CURVE GEOMETRY IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE DATA AND INFORMATION PROVIDED, THE CUSTOMER ISSUE SEEMS ISOLATED. 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¿ LOT 3005986. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

REPORT 1 OF 2 IT WAS REPORTED THAT KIT BD MAX CTGCTV2 US PATIENT SAMPLE WAS INITIALLY POSITIVE AND THEN NEGATIVE ON REPEAT RUN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX CTGCTV2 - 443904_3005986 - DISCREPANT RESULTS TWO PATIENT SAMPLES WERE INITIALLY POS, AND THEN THEY WERE BOTH NEG ON 2 REPEAT RUNS.

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.

Description of Event or Problem

REPORT 1 OF 2: IT WAS REPORTED THAT KIT BD MAX CTGCTV2 US PATIENT SAMPLE WAS INITIALLY POSITIVE AND THEN NEGATIVE ON REPEAT RUN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX CTGCTV2 - 443904_3005986 - DISCREPANT RESULTS. TWO PATIENT SAMPLES WERE INITIALLY POS, AND THEN THEY WERE BOTH NEG ON 2 REPEAT RUNS.