BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1022211 · Received March 26, 2008

    Report

    Report Number
    1823260-2008-02796
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ACCOUNT EXPERIENCING GETTING LOW SODIUM RESULTS, WHICH RECOVER HIGHER WHEN REPEATED, FOR MULTIPLE PATIENT SAMPLES. ONLY THE FOLLOWING PATIENT SAMPLE WAS PROVIDED AS AN EXAMPLE: INITIAL RESULT GAVE 127 MMOL/L; REPEAT GAVE 137 MMOL/L. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE DUE TO WORN SAMPLE TRANSFER CHAIN CABLES, AND REPLACED CHAIN CABLES AND SAMPLE SYRINGES.

    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