BD MAX¿ CDIFF

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR POSITIVE SAMPLE WITH STRANGE CURVE AND LOW CT VALUE WHEN USING THE BD MAX¿ CDIFF EU ASSAY (REF. 442555) LOT 5107370 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE REVIEW OF QUALITY CONTROL RECORDS OF BD MAX¿ CDIFF EU ASSAY LOT 5107370 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. CUSTOMER REPORTED UNEXPECTED POSITIVE RESULT FOR ONE SAMPLE WITH A STRANGE CURVE AND LOW CT VALUE WHEN USING THE BD MAX¿ CDIFF ASSAY. UPON RETESTING, THE SAME SBT GENERATED A NEGATIVE RESULT, AND A NEWLY PREPARED SAMPLE ALSO TESTED NEGATIVE. CUSTOMER PROVIDED ONE RUN FILE IN PDF FORMAT FROM RUN 5679 FOR THE INVESTIGATION. SINCE THE CSV FILE WAS NOT AVAILABLE TO PERFORM MANUAL PCR CURVE ADJUDICATION, THE INVESTIGATION WAS LIMITED, HOWEVER, REVIEW OF THE PDF FILE REVEALED AN UNUSUAL AMPLIFICATION CURVE IN POSITION A2, GIVEN AN EARLY CT VALUE AND A VERY LOW EP THAT REACHED THE THRESHOLD, RESULTING IN A POSITIVE CDIFF TARGET RESULT. NEVERTHELESS, IT IS UNLIKELY THAT THIS POSITIVE RESULT REPRESENTS TRUE AMPLIFICATION, CONSIDERING VALUES INCONSISTENT WITH THOSE EXPECTED. IN ADDITION, THE CUSTOMER PERFORMED TWO ADDITIONAL TESTS USING THE SAME SAMPLE BUFFER TUBE (SBT) AND A FRESH NEW SAMPLE PREPARATION; BOTH TESTED NEGATIVE FOR THE CDIFF TARGET. NONETHELESS, VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE DATA AND INFORMATION PROVIDED, NO ROOT CAUSE WAS IDENTIFIED. BASED ON THE COMPLAINT HISTORY REVIEW, THE BHR RECORDS ANALYSIS AND THE CUSTOMER DATA ANALYSIS, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX CDIFF EU LOT 5107370. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED AT THIS TIME SINCE NO TREND WAS IDENTIFIED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD MAX¿ CDIFF, A FALSE POSITIVE PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. SAMPLE WAS SENT TO EXTERNAL LAB AND WAS CDIFF NEGATIVE. SAMPLE WAS REPEAT TESTED ON BD MAX¿ CDIFF AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

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 OF BD MAX¿ CDIFF, A FALSE POSITIVE PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. SAMPLE WAS SENT TO EXTERNAL LAB AND WAS CDIFF NEGATIVE. SAMPLE WAS REPEAT TESTED ON BD MAX¿ CDIFF AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.