KIT BD MAX CTGCTV2 US

Description of Event or Problem

IT WAS REPORTED THAT DURING TESTING WITH KIT BD MAX CTGCTV2 US A FALSE POSITIVE RESULT WAS OBTAINED. REPEAT TESTING WAS PERFORMED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT DISCREPANT RESULTS WHILE USING CAT 443904 LOT 3135908. CUSTOMER REPORTS SAME ISSUE AS WITH CASE (B)(4) . PER CUSTOMER, THE ISSUE IS WITH THE CTGCTV2 ASSAY. FOR THE ONE PATIENT, THE FIRST RUN THE CT WAS POSITIVE AND THE RE-RUN THE CT WAS NEGATIVE. THE SPECIMEN WAS VAGINAL SWAB.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD CTGCTV2 FOR BD MAX¿ (REF. 443904 ) LOT 3135908 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¿ INDICATED THAT LOT 3135908 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT ONE PATIENT SAMPLE THAT INITIALLY GAVE A CT POSITIVE RESULT (IN RUN 1242 POSITION A6) BUT TESTED NEGATIVE WHEN REPEATED (IN RUN 1246, POSITION B12). CUSTOMER PROVIDED THE TWO RUNS (1242 AND 1246) FROM INSTRUMENT CT2647 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED. SAMPLE FROM RUN 1242 POSITION A6 GAVE A CT POSITIVE RESULT, AND ANALYSIS OF THE RAW PCR CURVE IN FAM SHOWED WHAT APPEARS TO BE LATE BUT TRUE AMPLIFICATION OF THE CT TARGET. NO ANOMALY WAS OBSERVED IN THE CURVES. THE REPEAT TEST, IN RUN 1246, SHOWED FLAT CURVES IN EVERY CHANNEL, WITHOUT AMPLIFICATION NOR ANY ANOMALY. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE DATA AND INFORMATION PROVIDED, A SAMPLE AT OR NEAR THE LIMIT OF DETECTION (LOD) OR ENVIRONMENTAL OR CROSS CONTAMINATION ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS. 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 3135908. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. . BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT DURING TESTING WITH KIT BD MAX CTGCTV2 US A FALSE POSITIVE RESULT WAS OBTAINED. REPEAT TESTING WAS PERFORMED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT DISCREPANT RESULTS WHILE USING CAT 443904 LOT 3135908. CUSTOMER REPORTS SAME ISSUE AS WITH CASE (B)(4). PER CUSTOMER, THE ISSUE IS WITH THE CTGCTV2 ASSAY. FOR THE ONE PATIENT, THE FIRST RUN THE CT WAS POSITIVE AND THE RE-RUN THE CT WAS NEGATIVE. THE SPECIMEN WAS VAGINAL SWAB.

Additional Manufacturer Narrative

THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: D.1 MEDICAL DEVICE TYPE: MKZ, OUY H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.