BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOTYPE TEST

    MDR report key: 2065693 · Received April 17, 2011

    Report

    Report Number
    MW5020299
    Event Type
    Malfunction
    Date Received
    April 17, 2011
    Date of Event
    March 28, 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

    OUR LABORATORY REPORTED A HER2 FISH RESULT OF 2.29 LOW LEVEL AMPLIFICATION AND A POSITIVE PROGESTERONE ON THE VERY SAME TISSUE SENT TO (B)(6) FOR THE ONCOTYPE TEST. THE ONCOTYPE TEST REPORTED THE HER2 WAS NEGATIVE 8.5 UNITS, NEGATIVE <10.7 AND A NEGATIVE PROGESTERONE RECEPTOR. THESE FALSE NEGATIVE ONCOTYPE TEST RESULTS HAVE THE POTENTIAL FOR PT HARM-SPECIFICALLY IF THE PT DOES NOT RECEIVE HER2 TARGETED THERAPY. THE IMPACT OF THESE FALSE NEGATIVE RESULTS ON THE ONCOTYPE RECURRENCE SCORE REMAIN UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOTYPE TEST ONCOTYPE TEST NPQ GENOMIC HEALTH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR