BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 600 C501 MODULE

    MDR report key: 1193370 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07397
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS A LEAK FROM THE BACK OF ANALYZER ONTO THE FLOOR OVER A TWO DAY PERIOD. NO PATIENT SAMPLES WERE AFFECTED AND NO OPERATOR WAS HARMED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE CLOSED VALVES ON THE WATER TANK AFTER MAINTENANCE CAUSING THE PUMP HEAD TO BURN OUT. HE REPLACED THE PUMP HEAD AND PRIMED THE SYSTEM. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 600 C501 MODULE CLINICAL CHEMISTRY ANALYZER-CEM JJE ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK