BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 960706 · Received May 8, 2007

    Report

    Report Number
    1823260-2007-03867
    Event Type
    Malfunction
    Date Received
    May 8, 2007
    Date of Event
    April 19, 2007
    Report Date
    May 8, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INITIAL SODIUM RESULT OF 70 MEQ/L AND POTASSIUM RESULT OF 2.0 MEQ/L. SAME SAMPLE REPEATED 2 MORE TIMES GAVE RESULTS OF 75 MEQ/L AND 82 MEQ/L FOR SODIUM AND 2.1 MEQ/L AND 2.4 MEQ/L FOR POTASSIUM. THE SAME SAMPLE WAS REPEATED AGAIN IN 4/07 WITH THE FOLLOWING RESULTS: 137 MEQ/L FOR SODIUM AND 4.2 MEQ/L FOR POTASSIUM. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP DETERMINED THERE WAS AN ELECTRONIC FAILURE. THE INSTRUMENT WAS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR