BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIGNA

    MDR report key: 17855426 · Received September 29, 2023

    Report

    Report Number
    MW5146345
    Event Type
    Injury
    Date Received
    September 29, 2023
    Report Date
    September 26, 2023
    Manufacturer
    NANOSTRING TECHNOLOGIES, INC.
    Product Code
    NYI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    NANO[INVALID]PRODUCTS BRANDED AS VERACYTE DON'T WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568551 PROSIGNA CLASSIFIER, PROGNOSTIC, RECURRENCE RISK ASSESSMENT, RNA GENE EXPRESSION, BREAST NYI NANOSTRING TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L