BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1585348 · Received January 19, 2010

    Report

    Report Number
    1823260-2010-00330
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    December 29, 2009
    Report Date
    January 19, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE VALVE BODY ON THE WATER SUPPLY CONTAINER WAS CRACKED. DURING THE PREVIOUS NIGHT, IT LEAKED ONTO THE FLOOR. NO ONE SLIPPED OR FELL DUE TO THE LEAK. THE FIELD SERVICE REP REPLACED THE VALVE BODY CAP. MISHANDLING OF THE CAP CAN CAUSE IT TO CRACK. TO VERIFY ANALYZER OPERATION, HE RAN SEVERAL PATIENT SAMPLES AND OBSERVED NO WATER LEAKING FROM THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS 2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK