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

Device Problem False Negative Result (1225)

Patient Problem Viral Infection (2248)

Event Date 10/07/2022

Event Type  malfunction  

Event Description

[binaxnow] use for covid-19 under emergency use authorization (eua):[false negative covid-19 antigen tests by abbott binaxnow with 3 different tests and 2 different lot numbers.On the same day, flowflex(acon labs), ihealth and pcr were positive.I have photos of all antigen tests and another unused binaxnow kit from the same date.This false negative occurred with a covid-19 case that resulted in paxlovid rebound on day 17 through day 25.Fda safety report id # (b)(4).

• Brand Name: BINAXNOW COVID ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 15658626
• MDR Text Key: 302401595
• Report Number: MW5112784
• Device Sequence Number: 3
• 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: Physician
• Type of Report: Initial
• Report Date: 10/20/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White