BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC/ID-307

    MDR report key: 24349557 · Received February 16, 2026

    Report

    Report Number
    1119779-2026-00145
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    December 30, 2025
    Report Date
    January 23, 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
    KS, 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 BD PHOENIX¿ NMIC/ID-307 A PATIENT ISOLATE WAS MISIDENTIFIED AS SHIGELLA BOYDII. THE USER VERIFIED THE FINAL RESULT USING A REFERENCE LABORATORY. THE USER STATED, "SHIGELLA BOYDII WAS REPORTED AND SEEN BY THE DOCTOR. A REFERENCE LAB THAT THE ISOLATE WAS SENT TO, SENT BACK A RESULT OF "SHIGELLA NOT FOUND." THE CUSTOMER SUSPECTS THAT THE PATIENT WAS TREATED BUT DOES NOT HAVE DETAILS. ALL ANTIBIOTICS FOR THE ISOLATE WERE SENSITIVE." NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411767 BD PHOENIX¿ NMIC/ID-307 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5273384 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown