BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1052454 · Received May 22, 2008

    Report

    Report Number
    1823260-2008-04258
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 22, 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 FREE T4 RESULTS THAT DO NOT FIT WITH CLINICAL PICTURE ARE DISCREPANT WHEN REPEATED BY ANOTHER METHOD. INITIAL FREE T4 RESULT GAVE 31.1 PMOL/L; REPEAT GAVE 21.4 PMOL/L. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. 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 49 YR