BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1191541 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07219
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED LEAK FROM UNDER THE ANALYZER. USER SATES NO ONE HAS SLIPPED OR FALLEN AND NO PT RESULTS HAVE BEEN AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE ISE RINSE BATH DRAIN TO WASTE WAS CLOGGED AND UNCLOGGED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK