BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1231141 · Received November 12, 2008

    Report

    Report Number
    1823260-2008-08344
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED A LEAK UNDER AND OUTSIDE OF THE ANALYZER. NO PT SAMPLES WERE AFFECTED. NO OPERATORS WERE HARMED. THE FIELD SERVICE REP DETERMINED THE REFILL SENSOR WAS STUCK IN WATER SUPPLY TANK RESULTING IN A SUPPLY PUMP FAILURE. HE CLEANED THE WATER SUPPLY TANK AND SENSORS AND REPLACED THE WATER SUPPLY PUMP. ON FOLLOW UP VISIT, HE CLEANED AND RETESTED THE VALVE OPERATION. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER - CEM JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK