BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOTYPE DX

    MDR report key: 2065669 · Received April 17, 2011

    Report

    Report Number
    MW5020298
    Event Type
    Malfunction
    Date Received
    April 17, 2011
    Date of Event
    March 8, 2011
    Report Date
    April 17, 2011
    Manufacturer
    GENOMIC HEALTH
    Product Code
    NPQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD AN ESTROGEN RECEPTOR (ER) PERFORMED IN OUR LAB BY IMMUNOHISTOCHEMISTRY THAT WAS POSITIVE FOR ER IN HER LOBULAR CARCINOMA OF BREAST. OUR RESULT WAS UNEQUIVOCALLY POSITIVE, EVEN ON THE VERY SAME TISSUE BLOCK SENT TO (B)(6) FOR THE ONCOTYPE TEST (THESE TUMORS ARE ALMOST INVARIABLY - 99.9% - POSITIVE FOR ER). THE ONCOTYPE TEST, (B)(6) REPORTED ER AS NEGATIVE. ER WEIGHS HEAVILY IN THE ONCOTYPE RECURRENCE SCORE, AND A NEGATIVE RESULT IN THIS CASE IS CLEARLY UNACCEPTABLE, MISLEADING, AND COULD LEAD TO SERIOUS PT HARM IF THE PT IS NOT TREATED WITH APPROPRIATE ANTI-ESTROGEN THERAPY.

    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 48 YR