BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA (400) SYSTEM

    MDR report key: 1770574 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09293
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 15, 2007
    Report Date
    October 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT WITH DISCREPANT SODIUM RESULTS. INITIAL RESULT GAVE 130 MMOL/L, SAME SAMPLE REPEATED GAVE 138 MMOL/L. INITIAL RESULT NOT REPORTED. THE USER PERFORMED MAINTENANCE AND TROUBLESHOOTING ACTIVITIES WHICH RESOLVED THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK