BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAF V600E (VE1) MM PAB

    MDR report key: 25332843 · Received May 29, 2026

    Report

    Report Number
    2028492-2026-02124
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 19, 2025
    Report Date
    May 29, 2026
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC.
    Product Code
    PZJ
    PMA / PMN Number
    DEN170030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE BENCHMARK ULTRA PLUS INSTRUMENT IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED A FALSE NEGATIVE RESULT FOR ONE PATIENT'S SAMPLE TESTED WITH BRAF V600E (VE1) MM PAB ON A BENCHMARK ULTRA PLUS INSTRUMENT. THE PATIENT'S SAMPLE SHOWED < 1 % OF CELLS EXPRESSING BRAF STAINING OF POSITIVE CD1A POSITIVE TUMOR CELLS. THE CASE WAS REPORTED AS NEGATIVE AND THE PATIENT WAS TREATED AS BRAF NEGATIVE. ONE YEAR LATER, THE CASE WAS INCLUDED IN A RESEARCH TRIAL AND THE MOLECULAR RESULT SHOWED A BRAF VE600 MUTATION. REMAINING UNSTAINED SLIDES OF THE PATIENT'S SAMPLE WERE SENT TO ANOTHER LABORATORY AND AGAIN, A BRAF VE600 MUTATION WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226159 BRAF V600E (VE1) MM PAB LYNCH SYNDROME TEST SYSTEM PZJ VENTANA MEDICAL SYSTEMS INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1