BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010

    MDR report key: 1760886 · Received July 12, 2007

    Report

    Report Number
    1823260-2007-06024
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    June 11, 2007
    Report Date
    July 12, 2007
    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

    INITIAL TSH RESULT >100 MIU/L AND FREE T4 RESULT OF 10 PMOL/L. SAME SAMPLE REPEATED USING DIFFERENT METHOD GAVE RESULT OF 74.66 MIU/L FOR TSH AND 5.94 FOR FREE T4. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR PLAVIX| TARDYFERON (IRON)| TAHOR| CARDENSIEL| ATACAND| LEVOTHYROX| CORDARONE| KARDEGIC| LASILIX