BD MAX¿ ENTERIC BACTERIAL PANEL

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL VARIOUS SALMONELLA POSITIVES HAVE OCCURRED AND ARE CULTURE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SINCE (B)(6) 2022 CUSTOMER HAS HAD 7-9 BD MAX SALMONELLA POSITIVES THAT ARE CULTURE NEGATIVES.

Additional Manufacturer Narrative

H6 INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY (REF. (B)(6) FROM LOTS 2195180, 2010379, 2117057, 2229135, 2151513 AND 2229132 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA, AND BY THE COMPLAINT¿S HISTORY REVIEW. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY INDICATED THAT THE LOTS 2195180, 2010379, 2117057, 2229135, 2151513 AND 2229132 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED SALM POSITIVE RESULTS FOR NINE SAMPLES WHICH ARE NEGATIVE IN CULTURE, AS WELL AS ONE NEGATIVE CONTROL. THESE RESULTS OCCURRED ON TWO DIFFERENT INSTRUMENTS (CT1257 AND CT0680) AND SIX DIFFERENT KIT LOTS. CUSTOMER PROVIDED THESE TWO DATABASES FOR INVESTIGATION. DATABASE OF INSTRUMENTS CT1257 AND CT0680 WERE ANALYZED, AND NO SPECIFIC ISSUE WAS IDENTIFIED. MANUAL PCR CURVE ADJUDICATION OF ALL SALM POSITIVE RESULTS REVEALED LATE AND LOW, BUT TRUE 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. NONETHELESS, NO REAGENTS ISSUE IS SUSPECTED. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, POSITIVES SAMPLES AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY OR AN ENVIRONMENTAL / CROSS CONTAMINATION CAN EXPLAIN THE CUSTOMER¿S POSITIVES RESULTS IN THE INITIAL TESTS. 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. SEE H.10.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL VARIOUS SALMONELLA POSITIVES HAVE OCCURRED AND ARE CULTURE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SINCE (B)(6) 2022 CUSTOMER HAS HAD 7-9 BD MAX SALMONELLA POSITIVES THAT ARE CULTURE NEGATIVES.

Additional Manufacturer Narrative

THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT#: 2010379. MEDICAL DEVICE EXPIRATION DATE: 15-JUL-2023. DEVICE MANUFACTURE DATE: 10-JAN-2022. MEDICAL DEVICE LOT#: 2195180. MEDICAL DEVICE EXPIRATION DATE: 11-NOV-2023. DEVICE MANUFACTURE DATE: 14-JUL-2022. MEDICAL DEVICE LOT#: 2117057. MEDICAL DEVICE EXPIRATION DATE: 18-NOV-2023. DEVICE MANUFACTURE DATE: 27-APR-2022. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.