BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1553321 · Received November 16, 2009

    Report

    Report Number
    1823260-2009-07849
    Event Type
    Malfunction
    Date Received
    November 16, 2009
    Date of Event
    October 19, 2009
    Report Date
    November 16, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER HAD LEAKING VALVE BODY ON THE DI WATER RESERVOIR. THE LEAK WAS CONTAINED IN THE ANALYZER, THERE WAS NO LEAKING ONTO THE FLOOR. NO ONE WAS INJURED AND NO ERRONEOUS RESULTS WERE GENERATED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE VALVE BODY CAP CRACKED CAUSING THE LEAK AND HE REPLACED THE CAP. CUSTOMER CALIBRATED AND RAN CONTROLS WHICH WERE ALL IN RANGE, THE PROBLEM WAS RESOLVED.

    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