BD MAX¿ ENTERIC BACTERIAL PANEL

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY (REF. 442963) FROM LOTS 3137722 AND 3137729 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 LOTS 3137722 AND 3137729 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT DISCREPANT STX RESULTS AND INCREASE OF STX POSITIVE RATE SINCE 2023-09-06 WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY KIT LOTS 3137722 AND 3137729. CUSTOMER PROVIDED DATABASE AND RUNS (220, 222, 223, 224 AND 226) FROM INSTRUMENTS CT2641 FOR INVESTIGATION. DATABASE ANALYSIS SHOWED THAT THE RATE OF STX POSITIVE RESULTS SLIGHTLY INCREASED IN SEPTEMBER 2023. MANUAL PCR CURVE ADJUDICATION ANALYSIS OF ALL THE STX POSITIVE RESULTS FOUND IN THE DATABASE, SINCE 2023-08-27 REVEALED TRUE POSITIVE RESULTS, WITHOUT ANY ANOMALY. MOST OF THE STX POSITIVE SAMPLES WERE RETESTED USING A NEW SAMPLE PREPARATION (NEW SAMPLE BUFFER TUBE) AND ALL GAVE THE SAME RESULT THAN THE INITIAL TEST. NO DISCREPANT RESULT WAS OBTAINED ON THIS BD MAX¿ INSTRUMENT. ACCORDING TO THE COMPLAINT TEXT AND ADDITIONAL INFORMATION RECEIVED FOR THE INVESTIGATION, THE DISCREPANCIES WERE OBTAINED AFTER RESULTS FROM SEVERAL VERIFICATION TESTS WERE PERFORMED USING OTHER ASSAYS (STX SHIGA 1 AND 2 ANTIGENS, ELISA, BIOFIRE GI PANEL PCR), WERE COMPARED TO THE BD MAX¿ RESULTS. CONSIDERING THAT THE LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS, AND BASED ON THE DATA PROVIDED, BD WAS UNABLE TO FIND THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS. THE ANALYSIS STRONGLY SUGGESTS TRUE POSITIVE RESULTS AND NO PRODUCT 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 THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY LOTS 3137722 AND 3137729. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. B.5:DESCRIBE EVENT: REPORT 3 OF 5. IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL, THERE WAS A FALSE POSITIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. B.6: RELEVANT TESTS: BIOFIRE, ELISA, ANTIGEN TESTING. D4. MEDICAL DEVICE LOT#: 3137722. D4. MEDICAL DEVICE EXPIRATION DATE: 02-NOV-2024. H4. DEVICE MANUFACTURE DATE: 17-MAY-2023. E.1 INITIAL REPORTER FIRST NAME: (B)(6). E.1. INITIAL REPORTER LAST NAME: (B)(6).

Description of Event or Problem

REPORT 3 OF 5: IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL, THERE WAS A FALSE POSITIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Description of Event or Problem

3 OF 6. IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL, THERE WERE SHIGA TOXIN FALSE POSITIVES: NO PATIENT IMPACT REPORTED. ID MAX CT MA STATE PH LAB (ELISA). L3681328837 37 NOT DETECTED.

Additional Manufacturer Narrative

THERE WERE MULTIPLE MEDICAL DEVICE TYPES. THE INFORMATION FOR EACH ADDITIONAL TYPE IS AS FOLLOWS: D.2. MEDICAL DEVICE TYPE: OOI, PCH. D.4. MEDICAL DEVICE LOT/EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.