BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1203482 · Received October 17, 2008

    Report

    Report Number
    1823260-2008-07725
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    October 11, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED A LEAK COMING FROM THE ANALYZER ONTO THE FLOOR AND INTO THE WALKWAY. NO PT SAMPLES WERE AFFECTED AND NO ONE WAS HARMED. THE CUSTOMER REFUSED FIELD SERVICE DISPATCH, STATING THEY CHANGED THE WATER BOTTLE TO RESOLVE THE ISSUE AND EXPERIENCED NO FURTHER LEAKS.

    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