BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1172264 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07048
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 31, 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 DETECTED FALSE HIGH FT3 RESULT FOR ONE PT. RESULT DOES NOT FIT WITH OTHER RESULTS. FT3 RESULT IS 10.7 PMOL/L, TSH RESULT IS 4.04 MIU/L, FT4 RESULT IS 18.6 PMOL/L. T3 RESULT PERFORMED BY ANOTHER LABORATORY IS 1.25 NMOL/L. NO INFO WAS PROVIDED TO DETERMINE IF FT3 RESULT WAS REPORTED. 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 UNK PREDNISOLON| SULFAZALAZINE