BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1234084 · Received November 4, 2008

    Report

    Report Number
    1823260-2008-08144
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 24, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED A LEAK COMING FROM THE WATER TANK OF THE ANALYZER DUE TO A BROKEN WATER TANK VALVE. NO ONE FELL OR WAS INJURED, AND NO PT SAMPLES WERE INVOLVED. THE FIELD SERVICE REP FOUND A VALVE BROKEN OFF OF THE WATER TANK, AND REPLACED COMPLETE WATER TANK ASSEMBLY. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPEC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK