BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULES

    MDR report key: 1234082 · Received November 4, 2008

    Report

    Report Number
    1823260-2008-08142
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 13, 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
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OPERATOR REPORTED A LEAK COMING FROM THE RIGHT CORNER OF THE ANALYZER AFTER PERFORMING MAINTENANCE. NO PT SAMPLES WERE INVOLVED AND NO OPERATORS WERE HARMED. THE FIELD SERVICE REP DETERMINED WHILE PERFORMING MONTHLY MAINTENANCE, THE OPERATOR DID NOT OPEN THE VALVES FROM THE WATER TANK CAUSING THE PUMP TO CIRCULATE AND CRACK. HE REPLACED THE MAGNETIC PUMP THE NEXT DAY. HE INITIALIZED THE INSTRUMENT AND NO LEAKS WERE DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULES IMMUNOCHEMISTRY ANALYZER CEM ROCHE DIAGNOSTICS C601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK