MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 4CT; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number	195-180
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The remainder of the investigation is in progress.A supplemental report will be provided pending completion, or upon receipt of new information.
Event or Problem Description
The consumer reported reagent exposure in her nose with the binaxnow covid-19 antigen self test performed on (b)(6) 2025.The consumer added reagent solution to swab and swabbed her nose with it.Per the consumer, she deviated from the procedure, reversed it and added reagent solution to swab before using it to swab her nose.The consumer was advised to rinse her nose with water and contact her healthcare provider if needed.The consumer confirmed there was no irritation, or any discomfort experienced due to the reagent exposure.
Additional Manufacturer Narrative
A product deficiency was not reported or found.Technical service was unable to provide the safety data sheet, as the customer was unresponsive.A supplemental report will be provided if any additional information is obtained.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.
Event or Problem Description
The consumer reported reagent exposure in her nose with the binaxnow covid-19 antigen self test performed on (b)(6) 2025.The consumer added reagent solution to swab and swabbed her nose with it.Per the consumer, she deviated from the procedure, reversed it and added reagent solution to swab before using it to swab her nose.The consumer was advised to rinse her nose with water and contact her healthcare provider if needed.The consumer confirmed there was no irritation, or any discomfort experienced due to the reagent exposure.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 4CT
• Common Device Name: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 21474674
• Report Number: 1221359-2025-00071
• Device Sequence Number: 19706104
• Product Code: QKP
• UDI-Device Identifier: 00811877011729
• UDI-Public: 010081187701172917260627100000911485
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EUA210264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/27/2026
• Device Catalogue Number: 195-180
• Device Lot Number: 0000911485
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female