MAUDE Adverse Event Report: COGNIVUE, INC. COGNIVUE THRIVE; COMPUTERIZED COGNITIVE ASSESSMENT AID, EXEMPT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Anxiety (2328)

Event Date 07/15/2021

Event Type  Injury  

Event Description

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.

• Brand Name: COGNIVUE THRIVE
• Type of Device: COMPUTERIZED COGNITIVE ASSESSMENT AID, EXEMPT
• Manufacturer (Section D): COGNIVUE, INC.
• MDR Report Key: 16185834
• MDR Text Key: 307662404
• Report Number: MW5114340
• Device Sequence Number: 1
• Product Code: PTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: JANUVIA 100, LISINOPRIL 40.
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White