BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HER2 DUAL ISH

    MDR report key: 5369068 · Received January 14, 2016

    Report

    Report Number
    2028492-2016-00001
    Event Type
    Injury
    Date Received
    January 14, 2016
    Date of Event
    March 12, 2015
    Report Date
    January 14, 2016
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC
    Product Code
    NYQ
    PMA / PMN Number
    P100027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER RUN REPORTS INDICATE THAT CORRECT STAINING, USING THE SAME PRODUCT (INFORM HER2 DUAL ISH DNA PROBE COCKTAIL), LOT D11446 WAS OBSERVED ON SLIDES RUN SIMULTANEOUSLY AS THE SUSPECT SLIDES.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES VENTANA'S ASSAY PRODUCED A FALSE POSITIVE RESULT RESULTING IN HERCEPTIN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27431 HER2 DUAL ISH NYQ VENTANA MEDICAL SYSTEMS, INC 780-4422 D11446

    Patients

    Seq Age Sex Outcome Treatment
    1 Other