BD MAX¿ ENTERIC BACTERIAL PANEL

Additional Manufacturer Narrative

(B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A CULTURE WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER HAS SEVERAL RESULTS IN WHICH TWO OR THREE PATHOGENS HAVE A POSITIVE RESULT WITH THE BD MAX IN THE STOOL, NOT ALL OF THEM COULD BE CONFIRMED WITH CULTURE."

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A CULTURE WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER HAS SEVERAL RESULTS IN WHICH TWO OR THREE PATHOGENS HAVE A POSITIVE RESULT WITH THE BD MAX IN THE STOOL, NOT ALL OF THEM COULD BE CONFIRMED WITH CULTURE."

Additional Manufacturer Narrative

H6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY (REF. (B)(4)) LOT 1243582 WAS PERFORMED BY THE VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED SEVERAL SAMPLES DISPLAYING POSITIVE RESULTS FOR TWO OR THREE TARGETS, THAT COULD NOT BE CONFIRMED IN CULTURE, WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL KIT FROM LOT 1243582. CUSTOMER PROVIDED ONE RUN FILE (B)(4) CONTAINING SAMPLE A1 POSITIVE FOR CAMPY AND SALM TARGET AND RUN (B)(4) PDF FILE CONTAINING SAMPLE A3 POSITIVE FOR THE SHG, STX AND THE CAMPY TARGETS. MANUAL PCR CURVE ADJUDICATION OF THESE BOTH POSITIVE RESULTS REVEALED LATE AND LOW AMPLIFICATIONS WITHOUT ANOMALY, INDICATIVE OF TRUE POSITIVE RESULTS. LOW POSITIVE SAMPLES CAN OCCUR DUE TO BACTERIAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BD WAS UNABLE TO IDENTIFY 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. HOWEVER, POSITIVES SAMPLES AT THE LIMIT OF DETECTION OF THE ASSAY OR AN ENVIRONMENTAL / CROSS CONTAMINATION CAN EXPLAIN THE CUSTOMER¿S POSITIVES RESULTS. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY LOT 1243582. 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 H10.