BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMEL MACCONKEY AGAR

    MDR report key: 21334326 · Received February 6, 2025

    Report

    Report Number
    MW5165786
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    November 29, 2024
    Report Date
    February 3, 2025
    Manufacturer
    REMEL, INC.
    Product Code
    JSI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOUR PATIENTS HAD SPUTUM CULTURES THAT RECOVERED YERSINIA ENTEROCOLITICA FROM (B)(6) 2024 THROUGH (B)(6) 2024. THE ORGANISM GREW ON REMEL BLOOD AGAR AND REMEL MACCONKEY AGAR. THIS IS BEING ENTERED AT THE REQUEST OF THE CDC (CENTERS FOR DISEASE CONTROL). LOT: 192515.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835636 REMEL MACCONKEY AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI REMEL, INC. 189712

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other REMEL BLOOD AGAR| REMEL MACCONKEY