BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOTYPE DX MULTIVARIATE INDEX

    MDR report key: 2113214 · Received May 27, 2011

    Report

    Report Number
    MW5020805
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    December 15, 2010
    Report Date
    May 27, 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 FDA APPROVED VYSIS FISH HER2 PROBE KIT DEMONSTRATED AN EQUIVOCAL RANGE HER2 TEST RESULT FOR THIS PT, BUT THE ONCOTYPE TEST FOR HER2 WAS NEGATIVE. THIS IS A SERIOUS TEST DISCREPANCY THAT CAN RESULT IN A PT WHO IS ELIGIBLE FOR TARGETED THERAPY WITH THIS RESULT, (WHICH IS CONSIDERED TO BE A POSITIVE RESULT) NOT GETTING TARGETED THERAPY BECAUSE OF THE ERRONEOUS FALSE ONCOTYPE RT-PCR HER2 RESULT. THE TEST DISCREPANCIES MAY CLOUD CLINICAL JUDGMENT. IF A CLINICIAN CHOOSES NOT TO TREAT THIS PT BASED ON THE ONCOTYPE HER2 RESULT, THE STANDARD OF CARE WILL NOT BE MET, AND LITIGATION BECOMES A SERIOUS ISSUE FOR THIS CASE. IN OUR EXPERIENCE, THE HER2 COMPONENT OF THE ONCOTYPE DX TEST MISSES 100% OF HER2 EQUIVOCAL CASES ASSAYED BY THE FDA APPROVED VYSIS PROBES.

    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 74 YR