BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1019674 · Received March 21, 2008

    Report

    Report Number
    1823260-2008-02655
    Event Type
    Malfunction
    Date Received
    March 21, 2008
    Date of Event
    February 5, 2008
    Report Date
    March 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ACCOUNT EXPERIENCING DISCREPANT RESULTS FOR SODIUM AND OR POTASSIUM SINCE 2008. THE FOLLOWING 4 PT SAMPLES WERE PROVIDED; PT 1, IN 2008, INITIAL SODIUM RESULT GAVE 114.5 MEQ/L; REPEATED TWICE GAVE 138.8 MEQ/L. PT 2, IN 2008, INITIAL SODIUM RESULT GAVE 111.8 MEQ/L; REPEAT GAVE 129.7 MEQ/L. PT 3, IN 2008, INITIAL POTASSIUM GAVE 5.2 MEQ/L; REPEATED TWICE GAVE 4.0 MEQ/L EACH TIME. PT 4, IN 2008, INITIAL SODIUM GAVE 121.2 MEQ/L; REPEAT GAVE 137.3 MEQ/L. ERRONEOUS RESULTS WERE NOT REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    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