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

Device Problem False Negative Result (1225)

Patient Problem Viral Infection (2248)

Event Date 12/17/2022

Event Type  malfunction  

Event Description

Received 3 false negative antigen test all 24 hours apart with symptoms from day 0-3.Was only exposed to household of covid and nothing else.Received a pcr that was positive on day 3.Binaxnow test.

• Brand Name: BINAXNOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 16042370
• MDR Text Key: 306094011
• Report Number: MW5113931
• Device Sequence Number: 2
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/21/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2022
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White