BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1780187 · Received September 21, 2007

    Report

    Report Number
    1823260-2007-08266
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    September 2, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT SODIUM AND POTASSIUM RESULTS. INITIAL RESULTS WERE 109 MMOL/L FOR SODIUM AND 3.0 MMOL/L FOR POTASSIUM. SAME SAMPLE REPEATED RECOVERED 129 MMOL/L FOR SODIUM AND 3.6 MMOL/L FOR POTASSIUM. INITIAL RESULTS WERE REPORTED. PT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCY.

    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 NA