BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1172226 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07050
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 19, 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

    USER RECEIVED DISCREPANT FREE T4 RESULTS FOR ONE PATIENT SAMPLE. INITIAL RESULT GAVE 28.7 PMOL/L; REPEAT ON DIFFERENT INSTRUMENT GAVE 22.0 PMOL/L. NO INFORMATION PROVIDED TO DETERMINE IF INITIAL RESULT WAS REPORTED, OR IF ANY ADVERSE EVENTS OCCURRED. IF ADDITIONAL INFORMATION 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 19 YR