BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOTYPE DX MULTIVARIATE INDEX

    MDR report key: 2113220 · Received May 27, 2011

    Report

    Report Number
    MW5020810
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 27, 2011
    Manufacturer
    GENOMIC HEALTH
    Product Code
    NPQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ESTROGEN RECEPTOR PERFORMED BY RT-PCR AND REPORTED ON THE ONCOTYPE DX TEST/DEVICE - (B)(6) WAS NEGATIVE ON THIS PT'S BREAST CANCER. HOWEVER, THE ESTROGEN RECEPTOR PERFORMED ON THE VERY SAME TISSUE BLOCK AS THE ONCOTYPE DX TEST WAS MODERATELY POSITIVE, WITH A SEMIQUANTITIVE HISTOSCORE OF 115/300. THE ONCOTYPE TEST IN THIS INSTANCE IS A FALSE NEGATIVE RESULT, THAT COULD HAVE RESULTED IN A DISASTROUS DECISION NOT TO TREAT THIS PT WITH HORMONAL THERAPY FOR HER BREAST CANCER. THE IMMUNOHISTOCHEMISTRY TEST RESULT WAS PERFORMED USING AN FDA CLEARED KIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR