BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC-312

    MDR report key: 24777481 · Received April 3, 2026

    Report

    Report Number
    1119779-2026-00605
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 18, 2026
    Report Date
    March 23, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904490820
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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, K023444, K023634, K023858, K033458, K042932, K060214, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K062945, K063486, K063573, K063811, K063824, K123404, K132674, K132909, K163637, K173252, K173523, K181665, AND K233986. 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-312 A PATIENT ISOLATE (PSEUDOMONAS AERUGINOSA) HAD A HIGH MIC (FALSE RESISTANT) RESULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840030 PANEL PHOENIX NMIC-312 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5324466 30382904490820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown