BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1083176 · Received July 24, 2008

    Report

    Report Number
    1823260-2008-05772
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT FREE T4 RESULTS. INITIAL RESULT GAVE 30.7 PMOL/L; REPEAT BY ANOTHER METHODOLOGY GAVE 15.4 PMOL/L. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE INCORRECT RESULT. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS E MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR