BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-311

    MDR report key: 24389360 · Received February 19, 2026

    Report

    Report Number
    1119779-2026-00224
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    February 5, 2026
    Report Date
    February 12, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904494521
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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)#: K020322, K022129, K023444, K023634, K023858, K024153, K031530, K031699, K031912, K032299, K032567, K032655, K033362, K033458, K033560, K041384, K042932, K052269, K060214, K060217, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, AND K06382. 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-311 A PATIENT ISOLATE (KLEBSIELLA VARIICOLA) HAD FALSE RESISTANCE (HIGH MIC) WITH THE DRUGS ERTAPENEM AND MEROPENEM. THE USER VERIFIED THE FINAL RESULT USING KIRBY BAUER STATING THAT THE ISOLATE IS SENSITIVE TO BOTH DRUGS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458237 BD PHOENIX¿ NMIC-311 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5350901 30382904494521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown