BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    912 HITACHI

    MDR report key: 1140546 · Received August 28, 2008

    Report

    Report Number
    1823260-2008-06526
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED A WATER LEAK COMING FROM THE SIDE OF THE ANALYZER. NO INJURIES WERE REPORTED. NO PATIENT SAMPLES INVOLVED. THE FIELD SERVICE REPRESENTATIVE FOUND THE TUBING. PERFORMANCE TESTS WERE PERFORMED, INSTRUMENT OPERATES SATISFACTORILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 912 HITACHI CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS 912

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK