BD MAX¿ CDIFF (US)

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD MAX¿ CDIFF (US), A FALSE POSITIVE PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. SAMPLE WAS REPEATED AND WAS C. DIFF NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: INTRODUCTION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ CDIFF EU ASSAY (REF. (B)(4)) LOT 5142231 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE CUSTOMER REPORTED SUSPECTED FALSE POSITIVE RESULTS FOR PATIENT SAMPLES TESTED WITH THE BD MAX¿ CDIFF ASSAY KIT LOT 5142231. THE ISSUE HAPPENED ON TWO DIFFERENT BD MAX¿ INSTRUMENTS, (B)(6). BATCH HISTORY REVIEW: THE REVIEW OF QUALITY CONTROL RECORDS OF BD MAX¿ CDIFF EU LOT 5142231 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. INVESTIGATIONAL TESTING: CUSTOMER PROVIDED RUN 2940 FROM BD MAX¿ INSTRUMENT (B)(6) AND RUN 5610 FROM BD MAX¿ INSTRUMENT CT1276 FOR THE INVESTIGATION. MANUAL PCR CURVE ADJUDICATION OF THE SUSPECTED FALSE POSITIVE SAMPLES FROM RUN 2940 (B)(6) SHOWED ATYPICAL AMPLIFICATION CURVES WITHOUT SIGMOIDAL SHAPE IN POSITIONS A7, A9, A10 AND A11 SHOWING EARLY CT VALUES WITH LOW EP VALUES THAT REACHED THE THRESHOLD TO BE CONSIDERED POSITIVE FOR THE CDIFF TARGET. BASED ON THE ANALYSIS, IT IS UNLIKELY THAT THESE FOUR POSITIVE RESULTS REPRESENT TRUE AMPLIFICATION. FURTHERMORE, REVIEW OF THE RAW AMPLIFICATION CURVES IN THE FAM CHANNEL INDICATED POTENTIAL THERMAL CROSSTALK IN SAMPLES A7, A9, A10 AND A11. THIS INFORMATION WAS TRANSFERRED TO BD SERVICE FOR FURTHER INVESTIGATION, AND A SERVICE CASE HAS BEEN OPENED TO ASSESS INSTRUMENT (B)(6). ACCORDING TO THE CUSTOMER, THE PATIENT SAMPLES WERE REPEATED AND SUBSEQUENTLY YIELDED NEGATIVE RESULTS, FURTHER SUGGESTING FALSE POSITIVE RESULTS ON THE INITIAL TEST. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE CURRENT INVESTIGATION AND INFORMATION PROVIDED, BD COULD NOT DETERMINE THE EXACT CAUSE FOR THE CUSTOMER'S FALSE POSITIVE RESULTS OBTAINED ON THE INSTRUMENT (B)(6), ALTHOUGH NO REAGENT ISSUE IS SUSPECTED. CUSTOMER ALSO MENTIONED ANOTHER PROBLEMATIC SAMPLE IN RUN 5610 ON INSTRUMENT (B)(6). MANUAL PCR CURVE ADJUDICATION WAS ALSO CONDUCTED ON THIS SUSPECTED FALSE POSITIVE SAMPLE OBTAINED WHEN USING THE OTHER BD MAX¿ INSTRUMENT AND REVEALED AN ATYPICAL CURVE IN POSITION B1/RUN5610, WITH A LATE CT VALUE AND A LOW EP THAT REACHED THE THRESHOLD TO BE CONSIDERED A POSITIVE CDIFF RESULT. HOWEVER, UPON ANALYSIS OF THE SIGNAL USING A MAGNIFIED SCALE IN THE FAM CHANNEL (CDIFF TARGET), THE CURVE DOES NOT SHOW SIGMOIDAL SHAPE FOR SAMPLE B1 AND IT IS UNLIKELY THAT THE POSITIVE RESULT FOR THE CDIFF TARGET IS THE RESULT OF TRUE AMPLIFICATION. THE FACT THAT THE REPEAT TEST WAS NEGATIVE FOR THIS SAMPLE FURTHER SUPPORTS THIS HYPOTHESIS. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. 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 5142231. CONCLUSION: 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.

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 (US), A FALSE POSITIVE PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. SAMPLE WAS REPEATED AND WAS C. DIFF NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.