BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTAFLOW-CUP

    MDR report key: 22188143 · Received June 11, 2025

    Report

    Report Number
    MW5171346
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    November 16, 2022
    Report Date
    June 1, 2025
    Manufacturer
    ADVIN BIOTECH, INC.
    Product Code
    DKZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INTRINSIC INTERVENTIONS IS DISTRIBUTING URINE SCREEN DEVICES TO CHILD SERVICES AGENCIES WHICH ARE LABELED FOR FORENSIC USE ONLY. THEY ALSO SELL DEVICES THAT ARE FDA CLEARED ALLEGEDLY. THEY ARE MISREPRESENTING THE PRODUCT AND ITS INTENDED FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814886 VISTAFLOW-CUP ENZYME IMMUNOASSAY, AMPHETAMINE DKZ ADVIN BIOTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other