BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC/ID-307

    MDR report key: 25218572 · Received May 19, 2026

    Report

    Report Number
    1119779-2026-00801
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    March 22, 2026
    Report Date
    April 27, 2026
    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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA /510(K)#: G4. PMA / 510(K)# K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320, K181665, K033458 AND K123266. H3. 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 · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT URINE ISOLATE (ESCHERICHIA COLI) WAS MISIDENTIFIED AS CITROBACTER BRAAKI. THE USER VERIFIED THE FINAL RESULT USING REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197377 BD PHOENIX¿ NMIC/ID-307 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5336519 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown