BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1221551 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08197
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 14, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OPERATOR REPORTED ANALYZER LEAKING WATER ALL OVER THE FLOOR. NO PT SAMPLES WERE AFFECTED AND NO OPERATORS WERE HARMED. THE FIELD SERVICE REPRESENTATIVE DETERMINED A SURGE IN WATER PRESSURE HAD CAUSED THE WATER INPUT LINE TO FALL OFF CAUSING THE LEAK. HE RECONNECTED THE WATER INPUT LINE AND RAIN INSTRUMENT WITH NO LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CEMHISTRY ANALYZER-CEM CEM ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK