BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIECURE

    MDR report key: 24416238 · Received February 23, 2026

    Report

    Report Number
    MW5184224
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Report Date
    February 15, 2026
    Manufacturer
    VIE CURE INC.
    Product Code
    QIC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM REPORTING A CRITICAL DATA INTEGRITY FAILURE AND BIORESEARCH MISCONDUCT INVOLVING CLINICAL RESEARCH DATA THAT SUPPORTS FDA-CLEARED SOFTWARE AND DIAGNOSTICS. OBJECTIVE FORENSIC EVIDENCE CONFIRMS THE MANUAL FABRICATION OF CLINICAL PEDIGREE DATA. SPECIFICALLY, A PARTICIPANT RECORD WAS MANUALLY OVERRIDDEN (PRETEXTUAL ADDENDUM DATED (B)(6) 2015) TO SHOW A RELATIVE WAS DIAGNOSED AT AGE 58 DESPITE HAVING DIED AT AGE 54. THIS BINARY LOGIC FAILURE WAS USED TO 'SCRUB' A 26-YEAR GEOGRAPHICAL HISTORY OF TOXICANT EXPOSURE (B)(6) AND REPLACE IT WITH FABRICATED GENETIC DATA. THIS FALSIFIED 'PRECISION MEDICINE' PROFILE WAS THEN USED TO INFORM CLINICAL DECISIONS, INCLUDING SURGICAL INTERVENTIONS AND GENETIC COUNSELING. AS THIS DATA IS INTEGRATED INTO COMMERCIAL CLINICAL DECISION SUPPORT SYSTEMS (VIECURE), IT CONSTITUTES A SIGNIFICANT RISK TO PATIENT SAFETY AND THE EFFICACY OF FDA-REGULATED DIAGNOSTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473553 VIECURE HIV-1 GENOTYPING ASSAY USING NGS TECHNOLOGY QIC VIE CURE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other