BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1763627 · Received June 3, 2007

    Report

    Report Number
    1823260-2007-05790
    Event Type
    Malfunction
    Date Received
    June 3, 2007
    Date of Event
    June 13, 2007
    Report Date
    July 3, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    EXPERIENCING INTERMITTENT DISCREPANT SODIUM RESULTS FOR APPROXIMATELY ONE MONTH. THE FOLLOWING EXAMPLE WAS PROVIDED, INITIAL RESULT 132 MMOL/L, SAME SAMPLE REPEATED MULTIPLE TIMES GAVE RESULTS OF 142, 132, 132, 142, 141 MMOL/L. INITIAL RESULT WAS NOT REPORTED. 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 JGS ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA N/P - N/P