MAUDE Adverse Event Report: ABBOTT BINAXNOW COVID-18 ANTIGEN SELF TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 180075

Device Problem False Negative Result (1225)

Patient Problem Viral Infection (2248)

Event Date 12/19/2022

Event Type  malfunction  

Event Description

Initially took pilot covid test that came back positive used multiple other tests to confirm however they came back negative.Was able to confirm positivity via lab test.Took multiple tests which came back negative however pilot covid-19 at-home test came back positive which was confirmed with a lab test binaxnow - ref: 195-160 exp: 12/19/2022 lot: 180075, inbios - lot: bh7160 exp: 09/2023.

• Brand Name: BINAXNOW COVID-18 ANTIGEN SELF TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 16051201
• MDR Text Key: 306246335
• Report Number: MW5114002
• Device Sequence Number: 1
• Product Code: QKP
• 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: 12/22/2022
• 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 Expiration Date: 12/19/2022
• Device Lot Number: 180075
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White