BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1191581 · Received October 1, 2008

    Report

    Report Number
    1823260-2008-07300
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 15, 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 NINE PATIENT SAMPLES. THE FOLLOWING FOUR PATIENT EXAMPLES WERE PROVIDED. SAMPLE 1 INITIAL RESULT 133 MMOL/L, REPEAT 140 MMOL/L. SAMPLE 2 INITIAL RESULT 132 MMOL/L, REPEAT 139 MMOL/L. SAMPLE 3 INITIAL RESULT 130 MMOL/L, REPEAT 138 MMOL/L. SAMPLE 4 INITIAL RESULT 126 MMOL/L, REPEAT 133 MMOL/L. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE THE ISE TUBING WAS NOT BEING PINCHED OFF CORRECTLY DUE TO SALT DEPOSITS AROUND THE PINCH VALVES, AND CLEANED PINCH VALVES, CHECKED ISE TUBING AND ISE FLOW PATH. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    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