MAUDE Adverse Event Report: ABBOTT BINAXNOW; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 221443

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

Patient Problem Viral Infection (2248)

Event Date 03/12/2023

Event Type  Injury  

Event Description

After taking paxlovid, four days later i tested positive for covid-19.No symptoms on (b)(6) 2023.Positive test was validated by using two different manufactures' test kits."pfizer".Reference report: mw5115755.

• Brand Name: BINAXNOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 16546757
• MDR Text Key: 311418596
• Report Number: MW5115754
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): Y
• 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: 03/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 05/24/2024
• Device Lot Number: 221443
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White