MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ABBOTT'S BINAX NOW COVID-19 AG AT-HOME TEST KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problems Output Problem (3005); Missing Test Results (3267)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2021

Event Type  malfunction  

Event Description

Abbott binaxnow covid-19 ag card home test - 2 pack use for covid-19 under emergency use authorization (eua).Home tests performed per manufacture's process including video proctoring.Abbott or emed was unable to provide a report despite negative testing.No customer support.Home test performed but emed did not produce a report, additional unnecessary testing was required.Fda safety report id # (b)(4).

• Brand Name: ABBOTT'S BINAX NOW COVID-19 AG AT-HOME TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 12384225
• MDR Text Key: 268940535
• Report Number: MW5103544
• 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: Physician
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 91