BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1191583 · Received October 1, 2008

    Report

    Report Number
    1823260-2008-07298
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 12, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING ERRATIC ISE RESULTS FOR APPROXIMATELY 10 PATIENT SAMPLES. THE FOLLOWING THREE PATIENT EXAMPLES WERE PROVIDED. SAMPLE 1 INITIAL RESULT 140 MMOL/L, REPEAT 132 MMOL/L. SAMPLE 2 INITIAL RESULT 133 MMOL/L, REPEAT 141 MMOL/L. SAMPLE 3 INITIAL RESULT 124 MMOL/L, REPEAT 130 MMOL/L. ONLY INITIAL RESULT FOR SAMPLE 3 WAS REPORTED. USER STATED PATIENT WAS NOT TREATED BASED ON THE RESULT AND A CORRECTED REPORTED WAS REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A PROBLEM WITH THE ELECTRODES AND REPLACED ELECTRODES. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK