BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOTYPE DX

    MDR report key: 2065662 · Received April 17, 2011

    Report

    Report Number
    MW5020297
    Event Type
    Malfunction
    Date Received
    April 17, 2011
    Date of Event
    March 31, 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

    THIS DISCREPANCY IN HER2 TEST RESULT WAS BROUGHT TO MY ATTENTION BY AN ONCOLOGIST. THE ONCOTYPE TEST, (B)(6) REPORTED HER2 AS NEGATIVE 9.1 UNITS, NEGATIVE <10.7, WHEREAS OUR FISH LAB REPORTED THE HER2 AS EQUIVOCAL WITH A RATIO OF 1.99. THERE IS POTENTIAL PT HARM IF THIS PT IS DENIED TARGETED HER2 THERAPY ON THE BASIS OF THE ONCOTYPE TEST RESULT.

    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 60 YR