BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1191542 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07220
    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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS A LEAK COMING FORM UNDER THE ANALYZER TO THE SURROUNDING AREA. USER STATES NO PT RESULTS HAVE BEEN AFFECTED AND NO USER WAS HARMED. THE FIELD SERVICE REPRESENTATIVE DETERMINED A PLUGGED ISE SAMPLE PROBE WASTE LINE TO BE THE CAUSE AND REMOVED THE CLOG. PERFORMANCE CHECKS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK