BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1172341 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07057
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING LOW SODIUM RESULTS FOR SEVERAL DAYS. IT WAS ESTIMATED THAT 5-10 PATIENT SAMPLES WERE INVOLVED, BUT AN EXACT NUMBER WAS NOT GIVEN. ONE EXAMPLE WAS PROVIDED. INITIAL RESULT 132 MMOL/L, REPEAT 139 MMOL/L. INITIAL RESULT WAS NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE THE AIR MIX AND DRY PRESSURES FOR THE ISE MODULE AND ADJUSTED THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR