BD CTGCTV2 FOR BD MAX¿ SYSTEM

Description of Event or Problem

REPORT 2 OF 5: IT WAS REPORTED THAT DURING USE OF MAX CTGCTV2, A TRICHOMONAS VAGINALIS FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLE WAS RETESTED USING THE MAX VAGINAL PANEL ASSAY AND WAS TRICHOMONAS VAGINALIS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY - THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX CTGCTV2 (REF. 443904) KIT LOTS 4194218 AND 4121726 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER REPORTED OBTAINING A TRICHOMONAS VAGINALIS (TV TARGET) POSITIVE RESULT WHEN USING BD MAX CTGCTV2 KIT FROM LOTS 4194218 THAT TESTED NEGATIVE WHEN SENT TO A REFERENCE LAB. THE TV POSITIVE SAMPLE ALSO TESTED FOR THE TV TARGET WHEN USING BD MAX VAGINAL PANEL ASSAY (REF. 443712) FROM LOT 4192205 AND STAYED POSITIVE. CUSTOMER ALSO OBTAINED FOUR DISCREPANT TV RESULTS THAT TESTED NEGATIVE WHEN USING THE BD MAX CTGCTV2 KIT LOT 4121726 BUT POSITIVE WHEN USING THE BD MAX VAGINAL PANEL ASSAY FROM LOT 4054189. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX CTGCTV2 KIT INDICATED THAT LOTS 4194218 AND 4121726 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUNS 2034, 2038, 2039, 2040, 2041 AND 2131 AND DATABASE FROM BD MAX INSTRUMENT CT1688 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED FOR THE FIVE SAMPLES REPORTED IN THE COMPLAINT TEXT. THE TV POSITIVE SAMPLE ANALYSIS REVEALED LATE AND LOW, BUT TRUE, TV POSITIVE RESULT. HOWEVER, THE FOUR NEGATIVE SAMPLES DISPLAYED A FLUORESCENCE DRIFT AND LOW ENDPOINT (EP) VALUES IN THE CY5 CHANNEL (TV TARGET). MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. FURTHER ANALYSIS REVEALED THAT THE ISSUE OCCURRED WHEN USING BD PCR CARTRIDGES (REF. 437519) LOT 4107497, WHICH, MAY BE A CONTRIBUTOR IN THE CUSTOMER REPORTED ISSUE ALTHOUGH PCR CARTRIDGES HAVE NOT BEEN IDENTIFIED AS A ROOT CAUSE FOR FALSE POSITIVE RESULTS WHEN USING THIS CARTRIDGE LOT WITH THE BD MAX VAGINAL PANEL ASSAY. THE MOST RECENT ENVIRONMENTAL MONITORING PERFORMED BY THE CUSTOMER CONFIRMED NO ENVIRONMENTAL CONTAMINATION FOR THIS TARGET IN THE LABORATORY. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX CTGCTV2 KIT LOTS 4194218 OR 4121726. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) OR CROSS CONTAMINATION IS THE MOST PROBABLE CAUSE OF THE CUSTOMER REPORTED ISSUE. MOREOVER, LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT TESTING METHODS. 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

D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY. 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

REPORT 2 OF 5: IT WAS REPORTED THAT DURING USE OF MAX CTGCTV2, A TRICHOMONAS VAGINALIS FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLE WAS RETESTED USING THE MAX VAGINAL PANEL ASSAY AND WAS TRICHOMONAS VAGINALIS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.