KIT BD MAX CTGCTV2 US

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE KIT BD MAX CTGCTV2 US, THERE WAS A FALSE POSITIVE RESULT FOR CHLAMYDIA. THE TEST WAS REPEATED WITH A NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX CT/GC/TV2 ASSAY (REF. (B)(4)) FROM LOT 3291406 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT A FALSE POSITIVE RESULT FOR CT TARGET WHEN USING THE BD MAX CT/GC/TV2 KIT LOT 3291406 THAT GAVE A NEGATIVE RESULT ON RERUN. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX CT/GC/TV2 ASSAY INDICATED THAT LOT 3291406 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED REPORTS OF RUNS 3470 AND 3479. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE SAMPLE THAT GAVE A POSITIVE RESULT FOUND IN RUN 3470; POSITION B7 REVEALING LATE AND LOW AMPLIFICATION, BUT TRUE, CT POSITIVE RESULT (FAM). THE REPEAT TEST FOUND IN RUN 3479; POSITION A10 SHOWS NO AMPLIFICATION AND NO ANOMALY. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. THE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMENS 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 RESULTS. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD MAX CT/GC/TV2 ASSAY LOT 3291406. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION 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.

Additional Manufacturer Narrative

D2B: ADDITIONAL MEDICAL DEVICE TYPES: 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 DURING USE WITH THE KIT BD MAX CTGCTV2 US, THERE WAS A FALSE POSITIVE RESULT FOR CHLAMYDIA. THE TEST WAS REPEATED WITH A NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.