BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMISTRY ANALYZER

    MDR report key: 21321191 · Received February 6, 2025

    Report

    Report Number
    21321191
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 8, 2025
    Report Date
    February 3, 2025
    Manufacturer
    ALFA WASSERMANN, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CHEMISTRY ANALYZER ISSUE (HOPPER ERROR, REPLACED WITH EXTRA HOPPER ON SITE). BACK-UP HOPPER IS NOW PRESENT. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351767 CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ALFA WASSERMANN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown