BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1191580 · Received October 1, 2008

    Report

    Report Number
    1823260-2008-07301
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 16, 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 LOW SODIUM RESULTS FOR FIVE PATIENT SAMPLES. SAMPLE 1 INITIAL RESULT 129 MMOL/L, REPEAT 140 MMOL/L. SAMPLE 2 INITIAL RESULT 130 MMOL/L, REPEAT 141 MMOL/L. SAMPLE 3 INITIAL RESULT 130 MMOL/L, REPEAT 141 MMOL/L. SAMPLE 4 INITIAL RESULT 125 MMOL/L, REPEAT 140 MMOL/L. SAMPLE 5 INITIAL RESULT 129 MMOL/L, REPEAT 139 MMOL/L. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A PROBLEM WITH THE ISE MIXING TOWER, PINCH VALVES AND FLUID FLOW. HE REPLACED THE ISE MIXING TOWER, PINCH VALVES AND CHECKED THE FLUID FLOW PATH. ON FOLLOW UP VISIT, HE DETERMINED THE LITHIUM ELECTRODE WAS LEAKING AND REPLACED THE ELECTRODE. 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