BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1162208 · Received September 16, 2008

    Report

    Report Number
    1823260-2008-06924
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS ANALYZER LEAKED ONTO THE FLOOR DURING WATER TANK REPLACEMENT. USER STATES NO ONE WAS INJURED AND NO PATIENT SAMPLES WERE INVOLVED. THE FIELD SERVICE REPRESENTATIVE DETERMINED AN AIR LOCK IN THE PUMP TO BE THE CAUSE AND HE FILLED THE WATER TANK AND BLED AIR LINES ON THE PUMPS. PERFORMANCE TESTES WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK