BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA 800

    MDR report key: 3112121 · Received June 19, 2006

    Report

    Report Number
    1823260-2006-07865
    Event Type
    Malfunction
    Date Received
    June 19, 2006
    Date of Event
    June 1, 2006
    Report Date
    June 1, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL RESULT FOR A PT SODIUM WAS 125 MMOL/L. WHEN REPEATED, THE RESULT WAS 138 MMOL/L. THE INCORRECT RESULT WAS NOT USED TO GUIDE THERAPY. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANT RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1