BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1221494 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08183
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 17, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED A LEAK FROM THE ANALYZER. NO PT SAMPLES WERE INVOLVED. NO OPERATORS WERE HARMED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE WATER BOTTLE CAPS WERE LEAKING AND REPLACED THE CAPS WITH BALL STOPCOCKS AND O-RINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK