BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T3 REAGENT IMMUNO 1

    MDR report key: 109291 · Received July 24, 1997

    Report

    Report Number
    1810909-1997-00011
    Event Type
    Malfunction
    Date Received
    July 24, 1997
    Date of Event
    March 1, 1997
    Report Date
    July 23, 1997
    Manufacturer
    BAYER CORP.
    Product Code
    CDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN MARCH OF 1997 A 80 YR OLD FEMALE PRESENTED CLINICAL SYMPTOMS OF GOITER AND HYPERTHYROIDISM. THE PT WAS TREATED WITH THYROID SUPPRESSING DRUGS. IT WAS STATED THAT DURING THE COURSE OF THIS TREATMENT HER TSH LEVEL ROSE TO AND HER T4 VALUES DECREASED TO HYPOTHYROID LEVELS. HOWEVER, HER T3 LEVEL AS MEASURED ON THE IMMUNO-1 REMAINED ELEVATED (ABOVE THE NORMAL RANGE). THE CLINICIANS CONTINUED THYROID SUPPRESSING TREATMENT BASED ON THE T3 RESULTS. IT IS BELIEVED THAT THE PT WAS MAD HYPOTHYROID DUE TO OVER SUPPRESSION OF HER THYROID FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T3 REAGENT IMMUNO 1 TEST OF T3 CDP BAYER CORP. T01-2949-01 T97405

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR