KIT BD MAX CTGCTV2 US

Additional Manufacturer Narrative

THERE WERE MULTIPLE MEDICAL DEVICE TYPES. THE INFORMATION FOR EACH ADDITIONAL TYPE IS AS FOLLOWS: D.2. MEDICAL DEVICE TYPE: MKZ, OUY. H3. 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 WHILE TESTING WITH THE KIT BD MAX CTGCTV2 US, THERE WAS A FALSE POSITIVE RESULT FOR TRICHOMONAS. THE SAMPLE WAS RECOLLECTED AND THE TEST WAS REPEATED WITH A NEGATIVE RESULT. BOTH SAMPLES WERE REPEATED AGAIN WITH NEGATIVE RESULTS. SAMPLE RECOLLECTION OCCURRED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX CTGCTV2 (REF (B)(4)) LOT 3352969 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT A OBTAINING A POSITIVE RESULT FOR TV THAT REPEATED AS NEGATIVE WHEN USING THE BD MAX CTGCTV2 LOT 3352969. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX CTGCTV2 LOT 3352969 INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUNS 1647 AND 1649, AND DATABASE FROM INSTRUMENT CT3056 THAT WERE ANALYZED. SPECIMEN ID OF THE DISCREPANT SAMPLE WAS IDENTIFIED BY THE CUSTOMER BUT THE INITIAL RUN FOR WHICH A TV POSITIVE RESULT WAS OBTAINED WAS NOT PROVIDED. BD WAS ABLE TO IDENTIFY RUN 1641; POSITION A11 AS THE ORIGINAL TEST BASED ON THE SPECIMEN ID. A RECOLLECTED SAMPLE WAS TESTED IN RUN 1647; POSITION B12 AND GAVE A NEGATIVE RESULT. BOTH SAMPLES WERE RETESTED ON RUN 1649 AND GAVE A NEGATIVE RESULT (INITIAL SAMPLE; POSITION A15 AND RECOLLECTED SAMPLE; POSITION A4). MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ON THE INITIAL TEST (RUN 1641; POSITION A11) AND SHOWED A STEP DISLOCATION IN THE RAW PCR SIGNAL IN ALL CHANNELS, RESULTING IN A POSITIVE RESULT FOR THE TV TARGET. IT IS UNLIKELY THIS POSITIVE RESULT IS THE RESULT OF TRUE AMPLIFICATION. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR ABERRANT CURVE GEOMETRY IS A CONSERVATIVE ASSESSMENT OF THE DATA. THE CURVES WERE ALSO REVIEWED BY A BD INSTRUMENT QUALITY ENGINEER AND NO INSTRUMENT ISSUE WAS IDENTIFIED. THE ROOT CAUSE WAS NOT IDENTIFIED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX CTGCTV2 LOT 3352969. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND A PREVENTIVE ACTION PLAN SINCE NO NEW HAZARD OR TRENDS WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE TESTING WITH THE KIT BD MAX CTGCTV2 US, THERE WAS A FALSE POSITIVE RESULT FOR TRICHOMONAS. THE SAMPLE WAS RECOLLECTED AND THE TEST WAS REPEATED WITH A NEGATIVE RESULT. BOTH SAMPLES WERE REPEATED AGAIN WITH NEGATIVE RESULTS. SAMPLE RECOLLECTION OCCURRED.