BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX NMIC-311

    MDR report key: 11665246 · Received April 14, 2021

    Report

    Report Number
    1119779-2021-00662
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 24, 2021
    Report Date
    September 2, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR DISCREPANT MIC RESULTS WHEN USING PHOENIX PANEL NMIC-311 (449452) BATCH NUMBERS 0231101, 0273231, AND 0294469. THE CUSTOMER DID PROVIDE LAB REPORTS AND ISOLATE RETURNS FOR INVESTIGATION.   CUSTOMER SUBMITTED ISOLATES, REPORTING QUESTIONABLY RESISTANT OR INTERMEDIATE RESULTS WHEN INITIALLY TESTED AND SUSCEPTIBLE RESULTS UPON SUBSEQUENT REPEAT TESTING. TO INVESTIGATE, A TOTAL OF TWENTY SIX (26) RETENTION PANELS FROM THE COMPLAINT BATCHES WERE TESTED USING A PHOENIX M50 INSTRUMENT USING THE RETURNED ISOLATES FROM THE CUSTOMER AND EVALUATED FOR MIC VALUES. TWO RUNS WERE PERFORMED TO ASSESS FOR ANY DISCREPANCIES IN MIC RESULTS. TWO OF THE RETURNED ISOLATES GAVE A RESISTANT OR INTERMEDIATE RESULTS ON THE FIRST RUN DURING INVESTIGATION. ON THE SECOND RUN, THESE RESULTS WERE SUSCEPTIBLE. A THIRD RUN WAS PERFORMED FOR THESE ISOLATES FOR VERIFICATION USING TEST PANELS FROM THE COMPLAINT BATCHES AND CONTROL PANELS. BOTH PANELS YIELDED SUSCEPTIBLE RESULTS FOR THE THIRD INVESTIGATIONAL RUN FOR ONE OF THE ISOLATES (8994305), BUT ISOLATE (8996438) TESTED SUSCEPTIBLE FOR THE RETENTION PANEL TESTED, BUT RESISTANT FOR THE CONTROL PANEL. THESE ISOLATES WERE TESTED BY DISK DIFFUSION FOR THE DRUGS IN QUESTION. THE DISK DIFFUSION RESULTS AFFIRMED THAT BOTH OF THESE ISOLATES YIELD RESULTS THAT ARE RIGHT ON THE BREAKPOINT FOR THE DRUGS IN QUESTION. ALL OTHER CUSTOMER RETURNED ISOLATES TESTED DURING INVESTIGATION DID NOT YIELD DISCREPANT RESULTS BETWEEN RUNS; ALL RUNS MATCHED THE SUSCEPTIBLE RESULTS OBSERVED BY THE CUSTOMER ON THE SECOND RUN AT THEIR LAB. IN SUMMARY, IT WOULD APPEAR THAT THE INITIAL RESISTANT OR INTERMEDIATE RESULTS OBTAINED BY THE CUSTOMER WERE FALSELY RESISTANT/INTERMEDIATE, MOST LIKELY DUE TO WORKFLOW ISSUES. THE CUSTOMER¿S SECOND RUN OF THE ISOLATES, WHICH YIELDED SUSCEPTIBLE RESULTS, MATCHED THE FINDINGS IN THIS INTERNAL INVESTIGATION, EXCEPT FOR THE TWO ISOLATES THAT HAVE MICS THAT FALL ON THE BREAKPOINT FOR THE DRUGS IN QUESTION. THIS COMPLAINT IS NOT CONFIRMED FOR DISCREPANT RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHOENIX¿ NMIC-311 PATTERNS DO NOT MATCH PHENOTYPE WITH MANY OF THE ANTIBIOTICS. PURITY PLATES ARE NOT CONTAMINATED AND AFTER REPEAT APPEAR NORMAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DISCREPANT RESULTS WITH NMIC-311. ALL GROWTH WAS CONFIRMED BY MALDI AS ACINETOBACTER LWOFFII. MIC PATTERNS DO NOT MATCH PHENOTYPE ACROSS A NUMBER OF ANTIBIOTICS, PURITY PLATES ARE NOT CONTAMINATED AND AFTER REPEAT RESULTS LOOK NORMAL.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0231101. MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2020-08-18. MEDICAL DEVICE LOT #: 0273231. MEDICAL DEVICE EXPIRATION DATE: 2021-10-31. DEVICE MANUFACTURE DATE: 2020-09-29. NUMEROUS DRUGS WERE REPORTED TO BE INVOLVED, HOWEVER, WE WERE NOT ABLE TO OBTAIN WHICH ONES, THEREFORE 510K INFORMATION IS NOT AVAILABLE. 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 · 1

    IT WAS REPORTED WHILE USING BD PHOENIX¿ NMIC-311 PATTERNS DO NOT MATCH PHENOTYPE WITH MANY OF THE ANTIBIOTICS. PURITY PLATES ARE NOT CONTRAMINATED AND AFTER REPEAT APPEAR NORMAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DISCREPANT RESULTS WITH NMIC-311. ALL GROWTH WAS CONFIRMED BY MALDI AS ACINETOBACTER LWOFFII. MIC PATTERNS DO NOT MATCH PHENOTYPE ACROSS A NUMBER OF ANTIBIOTICS, PURITY PLATES ARE NOT CONTAMINATED AND AFTER REPEAT RESULTS LOOK NORMAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565441 BD PHOENIX NMIC-311 SYSTEM, TEST, AUTO ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 0294469

    Patients

    Seq Age Sex Outcome Treatment
    1