BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOTYPE DX

    MDR report key: 2114540 · Received May 31, 2011

    Report

    Report Number
    MW5020846
    Event Type
    Injury
    Date Received
    May 31, 2011
    Date of Event
    January 25, 2011
    Report Date
    May 31, 2011
    Manufacturer
    GENOMIC HEALTH
    Product Code
    NPQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ONCOTYPE DX TEST REPORTED THIS PT AS BEING ESTROGEN RECEPTOR NEGATIVE BY THE RT-PCR METHOD. THIS MULTIVARIATE INDEX ASSAY/DEVICE IS A LAB DEVELOPED TEST. THIS PT HAD ESTROGEN RECEPTOR PERFORMED ON BOTH A CORE BIOPSY, AS WELL AS THE VERY SAME TISSUE BLOCK THAT WAS SENT FOR PERFORMANCE OF THE ONCOTYPE TEST. IN BOTH SPECIMENS, THE ESTROGEN RECEPTOR WAS POSITIVE USING FDA CLEARED TEST KITS FOR ESTROGEN RECEPTOR IMMUNOHISTOCHEMISTRY. THIS FALSE NEGATIVE RESULT CAN CAUSE CLINICAL CONFUSION AND MAY RESULT IN A PT NOT BEING TREATED, WHICH WOULD RESULT IN PREMATURE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOTYPE DX ONCOTYPE DX NPQ GENOMIC HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR