BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 22913697 · Received August 28, 2025

    Report

    Report Number
    1119779-2025-04399
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    May 30, 2023
    Report Date
    July 1, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G5. THE PANEL PHOENIX NMIC/ID-307 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320. "INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI AS ENTEROBACTER CLOACAE WHEN USING PHOENIX PANEL NMIC/ID-307 (449289) BATCH NUMBER 3059859. THE CUSTOMER DID NOT RETURN PANELS BUT PROVIDED AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW PATIENT ISOLATES IDENTIFIED AS E. CLOACAE. THE CUSTOMER RETURNED THREE ISOLATES THAT WERE RAN ON BRUKER MALDI AND VERIFIED AS E. COLI ISOLATES. TO INVESTIGATE, ONE RETENTION PANEL FROM THE COMPLAINT BATCH 3059859 AND ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATE E. COLI-1 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. NEXT, ONE RETENTION PANEL FROM THE COMPLAINT BATCH 3059859 AND ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATE E. COLI-2 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. LASTLY, ONE RETENTION PANEL FROM THE COMPLAINT BATCH 3059859 AND ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATE E. COLI-3 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. FOR A TOTAL OF SIX PANELS TESTED. ALL SIX PANELS IDENTIFIED THE ISOLATES AS E. COLI, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING PANEL PHOENIX NMIC/ID-307, A PATIENT SAMPLE OF E. COLI WAS INCORRECTLY IDENTIFIED AS E. CLOACAE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2608282 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 3059859 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown