MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH INC. ABBOTT BINAXNOW HOME APP; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2021

Event Type  malfunction  

Event Description

This test is useless.I am a computer programmer, and bought this test for my dad, a retired nurse.Between the 2 of us we should have the capacity to log in a take a simple test.But no.My dad has an (b)(6) and (b)(6), neither of which are enough to take the test.All this test needs is simple paper instructions instead of terrible technology.This "app" is ridiculous, and prevents people from taking a covid test.(b)(6).Fda safety report id# (b)(4).

• Brand Name: ABBOTT BINAXNOW HOME APP
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH INC.
• MDR Report Key: 11404037
• MDR Text Key: 234639264
• Report Number: MW5099725
• Device Sequence Number: 1
• Product Code: QKP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1