BD MAX¿ ENTERIC BACTERIAL PANEL

Additional Manufacturer Narrative

H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY (REF. (B)(4) LOTS 1074231 AND 1074241 WAS PERFORMED BY THE VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY INDICATED THAT THE LOTS 1074231 AND 1074241 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT TWO DISCREPANT SAMPLES WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL KIT LOTS 1074231 AND 1074241. THE FIRST PATIENT GAVE SHIG POSITIVE RESULTS DURING THE INITIAL TESTING, WHILE THE SECOND PATIENT GAVE SHIG AND STX POSITIVE RESULTS DURING THE INITIAL AND REPEAT TESTS, WHILE EXPECTED RESULT FOR BOTH SAMPLES WAS SALM POSITIVE. CUSTOMER PROVIDED THE DATABASE FROM INSTRUMENT CT1171 FOR INVESTIGATION. DATABASE ANALYSIS SHOWS THAT THE RUNS #1272 (FIRST PATIENT SAMPLE IN POSITION B8), #1214 (SECOND PATIENT SAMPLE, FIRST TEST IN POSITION B5) AND #1215 (SECOND PATIENT SAMPLE, REPEAT TEST IN POSITION B5) CONTAIN THE SUSPECTED FALSE POSITIVE RESULTS. MANUAL PCR CURVE ADJUDICATION OF THE SUSPECTED FALSE POSITIVE SAMPLES REVEALED TRUE AND STRONG AMPLIFICATIONS, WITH ENDPOINT FLUORESCENCE VALUES ABOVE 1000 AND CYCLE THRESHOLD VALUES AROUND 25-30 FOR THE 3 SAMPLES, INDICATIVE OF TRUE POSITIVE RESULTS. (SHIG OR SHIG AND STX TARGETS). BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S DISCREPANT RESULTS BUT BASED ON THE INVESTIGATION NO REAGENTS ISSUE IS SUSPECTED. THE ROOT CAUSE WAS NOT IDENTIFIED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY LOTS 1074231 AND 1074241. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED THAT WHILE TESTING WITH BD MAX¿ ENTERIC BACTERIAL PANEL A FALSE POSITIVE RESULT FOR SHIGELLA AND STX WERE OBTAINED AND A FALSE NEGATIVE FOR SALMONELLA. CONFIRMATORY TESTING WAS PERFORMED AND THE RESULT WERE NEGATIVE FOR SHIGELLA AND STX AND POSITIVE FOR SALMONELLA. ERRONEOUS RESULTS WERE NOT REPORTED AND IT IS UNKNOWN IF TREATMENT WAS PROVIDED BASED OFF OF RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT #2 OF 2: PATIENT #2. MAX: SHIGELLA POS, STX POS, SALMONELLA NEG. EXPECTED: SHIGELLA NEG, STX NRG, SALMONELLA POS (GAMINARA).

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 WHILE TESTING WITH BD MAX¿ ENTERIC BACTERIAL PANEL A FALSE POSITIVE RESULT FOR SHIGELLA AND STX WERE OBTAINED AND A FALSE NEGATIVE FOR SALMONELLA. CONFIRMATORY TESTING WAS PERFORMED AND THE RESULT WERE NEGATIVE FOR SHIGELLA AND STX AND POSITIVE FOR SALMONELLA. ERRONEOUS RESULTS WERE NOT REPORTED AND IT IS UNKNOWN IF TREATMENT WAS PROVIDED BASED OFF OF RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT #2 OF 2: PATIENT #2 MAX: SHIGELLA POS, STX POS, SALMONELLA NEG EXPECTED: SHIGELLA NEG, STX NRG, SALMONELLA POS (GAMINARA).