BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOTYPE DX MULTIVARIATE INDEX

    MDR report key: 2113237 · Received May 27, 2011

    Report

    Report Number
    MW5020809
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    May 17, 2011
    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

    THIS CASE IS UNEQUIVOCALLY AMPLIFIED FOR HER2 GENE BY THE FDA APPROVED VYSIS PROBE FISH KIT. THE ONCOTYPE RT-PCR TEST/DEVICE, A LABORATORY-DEVELOPED, MULTIVARIATE INDEX ASSAY, REPORTS AN EQUIVOCAL HER2 RESULT FOR THIS PT, WHICH IMPLIES TWO POTENTIALLY HARMFUL ISSUES TO THE PT, WHO IS A CANDIDATE FOR HER2 TARGETED THERAPY ACCORDING TO THE AMPLIFIED FISH RESULT: IT CLOUDS THE CLINICIAN'S JUDGEMENT ABOUT WHETHER TO GIVE HER2 THERAPY AND RAISES SERIOUS QUESTIONS ABOUT THE ROBUSTNESS OF THE OTHER 15 GENE COMPONENTS OF THE ONCOTYPE TEST, AND HENCE, THE RECURRENCE SCORE, WHICH IS THE CORE RESULT OF THE ONCOTYPE TEST. 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.

    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 48 YR