BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 1180821 · Received September 23, 2008

    Report

    Report Number
    1823260-2008-07111
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS THERE WAS A LEAK COMING FROM THE ANALYZER ONTO THE FLOW. USER STATED SHE CORDONED OFF THE AREA AND NOBODY HAD BEEN INJURED. NO PT SAMPLES WERE INVOLVED. THE FIELD SERVICE REPRESENTATIVE DETERMINED A BROKEN PRECLEAN NEEDLE TO BE THE CAUSE AND REPLACED THE NEEDLE. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK