BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1063001 · Received June 18, 2008

    Report

    Report Number
    1823260-2008-04812
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 26, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT WITH DISCREPANT CREATININE KINASE RESULTS. INITIAL RESULT 220 U/L, REPEAT 32,363 U/L. THE ERRONEOUS RESULT WAS REPORTED, PATIENT WAS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE BUT NOTED HE DECONTAMINATED THE FLUIDIC SYSTEM AND REPLACED F4 FILTER AND THE DEGASSER. ANALYZER RAN WITHOUT ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK