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

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Test Result (2695)

Event Date 11/06/2020

Event Type  malfunction  

Event Description

My daughter was given an abbott binaxnow ag card test by her school.Test was not clear, she took test twice.Second line was very faint, school ruled as positive since was test seemed inconclusive.I tested her soon after, twice and both test from independent labs came back negative.I feel that this product does not give the correct results and is handing out false positives.Should be looked into.Fda safety report id# (b)(4).

• Brand Name: ABBOTT BINAXNOW AG
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 10966936
• MDR Text Key: 220428194
• Report Number: MW5098232
• 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: 12/03/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 43