BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1200099 · Received October 15, 2008

    Report

    Report Number
    1823260-2008-07625
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A.M., USER EXPERIENCED LOW SODIUM, POTASSIUM AND CHLORIDE RESULTS. ONE PT EXAMPLE WAS PROVIDED. INITIAL SODIUM RESULT 118.9 MMOL/L, REPEAT 126.3 MMOL/L. INITIAL RESULT WAS REPORTED AND A CORRECTED REPORT WAS SENT TO WARD. PT WAS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED WORN TUBING UNDER THE MIX TOWER TO BE THE CAUSE AND REPLACED THE TUBING. PERFORMANCE CHECKS WERE PERFORMED AND WITHOUT SPECIFICATION.

    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 20 YR