BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIVUE THRIVE

    MDR report key: 16185834 · Received January 13, 2023

    Report

    Report Number
    MW5114340
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    July 15, 2021
    Report Date
    January 12, 2023
    Manufacturer
    COGNIVUE, INC.
    Product Code
    PTY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADVERSE EVENT RE:"COGNIVUE THRIVE," FDA REGISTERED ESTABLISHMENT NUMBER: (B)(4)COMPUTERIZED COGNITIVE ASSESSMENT DEVICE MFG. (B)(4). FROM: (B)(6), AGE 77, (B)(6) ADVERSE EVENT: I EXPERIENCED ACUTE ANXIETY ABOUT MY COGNITION STATUS AFTER BEING SUBJECTED TO A "COGNIVUE THRIVE" COMPUTERIZED COGNITIVE ASSESSMENT TOOL, "COGNITIVE SCREENING." MY COMPLAINT IS AGAINST COGNIVUE, INC., OF VICTOR, N.Y. FOR THE MANUFACTURING AND DISTRIBUTION OF THE "COGNIVUE THRIVE," WHICH HAS NO MEDICAL, DIAGNOSTIC VALUE FOR DETERMINING COGNITIVE FUNCTION. ON (B)(6) 2021, I WAS GIVEN A COGNIVUE THRIVE COGNITION TEST, WITHOUT MY INFORMED CONSENT BY AUDIOLOGIST (B)(6) (B)(4) AT (B)(6). I DID NOT REQUEST THE TEST, WHICH WAS GIVEN UNDER THE COLOR OF IT BEING PART OF A HEARING EXAM. MY PHYSICIAN'S, (B)(6), M.D. OF MIDVALLLEY FAMILY PRACTICE, REFERRAL ORDER WAS FOR A "HEARING TEST" ONLY, NOT A "COGNITION TEST." I LATER DISCOVERED FROM THE COGNIVUE, INC. WEB PAGES AND THE COGNIVUE THRIVE USER MANUAL THE FOLLOWING: FDA WARNINGS: "COGNIVUE THRIVE DOES NOT IDENTIFY THE PRESENCE OR ABSENCE OF CLINICAL DIAGNOSES." "COGNIVUE THRIVE CANNOT BE USED AS A STAND-ALONE DIAGNOSTIC" COGNIVUE THRIVE IS NOT FDA-CLEARED FOR USE BY NON-NEUROLOGISTS AND NON-PHYSICIANS TO TEST FOR COGNITIVE FUNCTION. ACCORDING TO A SAMPLE LETTER IN THE "THRIVE" USER MANUAL, "COGNIVUE THRIVE" HAS NO DIAGNOSTIC OR MEDICAL VALUE. COGNIVUE, INC. IS MARKETING THE "THRIVE" TOOL TO LAYPERSONS, NOT LICENSED OR QUALIFIED TO PROVIDE AND INTERPRET A COGNITION TOOL. THE TEST RESULTS CAN ONLY BE USED AS A "CONVERSATION STARTER" WITH A QUALIFIED AND LICENSED PRACTITIONER. THE "COGNIVUE THRIVE" TEST DID CAUSE ME GREAT, UNNECESSARY ANXIETY ABOUT MY COGNITIVE STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16228 COGNIVUE THRIVE COMPUTERIZED COGNITIVE ASSESSMENT AID, EXEMPT PTY COGNIVUE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other JANUVIA 100, LISINOPRIL 40.