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

Lot Number 208093

Patient Problem Viral Infection (2248)

Event Date 12/27/2023

Event Type  malfunction  

Event Description

I have 2 fda approved binanex home covid test sent by the government that were given extended expiration dates, gave false negatives.I thought i had a simple cold, that got progressively worse and i did not quarantine myself as i should have in the beginning.I took a covid test by a different brand that was not yet expired and got a positive.I took another binaxnow covid test, lot number 208093 with an expiration date of 09/09/2023 extended to the year 2024 and it was still showing me as negative although an unexpired test showed me positive.What if i had gone to work and decided to take cold meds to mask the symptoms so i could function and still wear just a mask to protect my patients , not knowing i had covid.This variant is apparently very contagious.God forbid i rely on another one of these expired tests with an "approved extended date".This is dangerous, people rely on the expertise of the fda and its regulatory board.Binaxnow lot number 208093 with an expiration date of 09/09/2023.Reference report #mw5149759, #mw5149760, #mw5149761.

• Brand Name: BINAXNOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 18444072
• MDR Text Key: 332143206
• Report Number: MW5149762
• Device Sequence Number: 1
• 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: 12/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/09/2023
• Device Lot Number: 208093
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female