BD MAX¿ ENTERIC BACTERIAL PANEL

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE BD MAX¿ ENTERIC BACTERIAL PANEL GAVE FALSE POSITIVE TEST RESULT. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLESIOMONAS WAS ISSUED 1 TIME AS NEGATIVE.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY (REF. (B)(4)) LOT 1257232 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. THE COMPLAINT WAS OPENED ON BD MAX¿ ENTERIC BACTERIAL PANEL LOT 1257232, USED IN COMBINATION WITH BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL (REF. (B)(4)) KIT LOT 1125116. BOTH LOTS WERE THUS INVESTIGATED. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC BACTERIAL PANEL (EBP) LOT 1257232 AND BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL (XEBP) LOT 1125116 INDICATED THAT THE LOTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE RETAIN MATERIAL OF BD MAX¿ ENTERIC BACTERIAL PANEL FROM LOT 1257232 AND BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL FROM LOT 1125116 WERE TESTED WITH XEBP POSITIVE TARGETS AND THE RESULTS WERE ALL CONFORMING. CUSTOMER REPORTED A FALSE NEGATIVE PLESIOMONAS TARGET RESULT WHEN TESTING AN EXTERNAL POSITIVE CONTROL WITH BD MAX¿ ENTERIC BACTERIAL PANEL KIT LOT 1257232. CUSTOMER ALSO NOTICED DIFFERENCES IN THE FLUORESCENCE DETECTION LEVELS COMPARED TO THE PREVIOUS LOT USED (LOT 1251609). CUSTOMER PROVIDED RUN FILES OF RUNS 3 AND 4 FROM INSTRUMENT MX0056 AND RUNS 2613 AND 2622 FROM INSTRUMENT CT0551 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS POSITIVE SAMPLE IN DATA PROVIDED. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. THE EXTERNAL PLESIOMONAS POSITIVE CONTROL THAT GAVE A NEGATIVE RESULT FOR WHICH THE CUSTOMER COMPLAINED WAS IDENTIFIED AS SAMPLE IN POSITION A5 OF RUN 3 FROM INSTRUMENT MX0056. FLUORESCENCE DETECTION LEVELS OF THE EXTERNAL POSITIVE CONTROLS IN THE VARIOUS RUNS WERE COMPARED BETWEEN LOTS 1257232 AND 1251609. ANALYSIS OF SAMPLES A5 (RUN 3), A2 (RUN 4), B3 (RUN 26220), A6 AND A7 (RUN 2613) REVEALED THAT THE SUSPECTED FALSE PLESIOMONAS NEGATIVE SAMPLE A5 (RUN 3) SHOWED LATE AND LOW FLUORESCENCE AMPLIFICATION IN THE CY5 CHANNEL THAT DID NOT REACH THE ASSAY THRESHOLD TO GIVE A POSITIVE RESULT. ALSO, STRONG FLUORESCENCE DETECTION IN THE CY5.5 (IC) CHANNEL AND IN ALL THE OTHER CHANNELS WERE OBSERVED FOR THIS SAMPLE, WHICH SUPPORTS AN ISSUE RELATED ONLY TO THE PLESIOMONAS TARGET. MOREOVER, FLUORESCENCE DETECTION LEVELS IN THE FAM, VIC, ROX AND CY5.5 CHANNELS, WERE STRONG AND COMPARABLE BETWEEN THE LOTS USED (LOT 1257232 (A5) AND 1251609). ALTHOUGH FLUORESCENCE DETECTION LEVELS WERE LOWER FOR THE CY5 CHANNEL (PLESIOMONAS. TARGET), THIS WAS OBSERVED FOR LOT 1251609 ALSO, TO A LESSER EXTENT. CONSIDERING THE LOWER FLUORESCENCE DETECTION FOR THE PLESIOMONAS TARGET COMPARED TO THE OTHER TARGETS REGARDLESS OF THE LOT USED, THIS COULD BE INDICATIVE OF A BACTERIAL TITER OF THE EXTERNAL POSITIVE CONTROL SAMPLES AT OR NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY. AS MENTIONED IN THE INSTRUCTION FOR USE, THE PLESIOMONAS TARGET POSITIVE EXTERNAL CONTROL SHOULD BE DILUTED AT 1.3X10E5 COLONY FORMING UNIT (CFU)/ML PRIOR TO INOCULATE THE SBT. BASED ON THE DATA AND INFORMATION PROVIDED, A POTENTIAL SPECIMEN MISHANDLING/IMPROPER CONTROL PREPARATION RESULTING IN A CONTROL SAMPLE BEING AT OR NEAR THE ASSAY LOD FOR PLESIOMONAS, IS THE MOST LIKELY CAUSE TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULT FOR THIS TARGET IN SAMPLE POSITION A5 OF RUN 3. BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S NEGATIVE RESULTS. NONETHELESS, NO REAGENTS ISSUE IS SUSPECTED. 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¿ ENTERIC BACTERIAL PANEL ASSAY LOT 1257232. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

Description of Event or Problem

IT WAS REPORTED THAT THE BD MAX¿ ENTERIC BACTERIAL PANEL GAVE FALSE POSITIVE TEST RESULT. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLESIOMONAS WAS ISSUED 1 TIME AS NEGATIVE.