BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1193390 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07432
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 7, 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 FT4 RESULTS FOR ONE PT SAMPLE. INITIAL RESULT WAS 42.6 (NO UNITS OF MEASURE PROVIDED). SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND GAVE 17.0 AND 17.9 (NO UNIT OF MEASURE GIVEN). SAMPLE WAS THEN MEASURED ON THE ORIGINAL ANALYZER AND GAVE 40.3 AND 40.2 (NO UNITS OF MEASURE GIVEN). 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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR