BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENIUS DIGITAL DIAGNOSTICS SYSTEM

    MDR report key: 25280577 · Received May 26, 2026

    Report

    Report Number
    1222780-2026-00332
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 26, 2026
    Manufacturer
    HOLOGIC, INC.
    Product Code
    QYV
    UDI-DI
    15420045513877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTED A DISCREPANCY IN DIAGNOSIS DURING A COMPARISON BETWEEN SYSTEMS AT THE SITE. THE CASE WAS INTERPRETED AS NEGATIVE ON THE GENIUS¿ DIGITAL DIAGNOSTICS SYSTEM AND POSITIVE ON THE IMAGER SYSTEM BY CYTOSCREENERS AND PATHOLOGISTS. NO DELAY IN PATIENT DIAGNOSIS OCCURRED. INTERNAL INVESTIGATION IS ONGOING AND RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98718 GENIUS DIGITAL DIAGNOSTICS SYSTEM GENIUS DIGITAL IMAGER QYV HOLOGIC, INC. GENIUS CAPITAL 15420045513877

    Patients

    Seq Age Sex Outcome Treatment
    1