BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1191551 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07215
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 6, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECOVERING LOW URINE SODIUM RESULTS FOR FOUR PATIENT SAMPLES. ONE EXAMPLE WAS PROVIDED. INITIAL RESULT 124 MMOL/L, REPEAT 138 MMOL/L. INITIAL RESULT WAS REPORTED. USER REFUSED TO PROVIDE ANY INFORMATION TO DETERMINE IF ANY ADVERSE EVENTS OCCURRED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A POSSIBLE PROBLEM WITH THE SODIUM ELECTRODE AND REPLACED IT. HE ALSO NOTED HE CHECKED THE ISE MODULE, CLEANED THE ISE SAMPLE FLOW PATH AND PERFORMED ELECTRODE SERVICE. 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