BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1437167 · Received April 21, 2009

    Report

    Report Number
    1823260-2009-02843
    Event Type
    Malfunction
    Date Received
    April 21, 2009
    Date of Event
    March 25, 2009
    Report Date
    April 21, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS HE HAS AN ELEVATED FREE T3 RESULT THAT DOES NOT FIT THE PT'S CLINICAL PICTURE, PT IS CLINICALLY EUTHYROID. THE PT'S FREE T3 RESULTS WERE PROVIDED: INITIAL ELECSYS RESULTS 11.2 PMOL PER L, VITROS RESULTS 5.5 PMOL PER L, AND RIA RESULTS 4.9 PMOL PER L. ELECSYS FREE T REAGENT LOT IS 182279. NO INFO WAS PROVIDED TO DETERMINE IF ANY ADVERSE EVENTS OCCURRED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATED NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS 2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR