MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF-TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number	195-160
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.
Event or Problem Description
The consumer reported pouring reagent on the swab prior to inserting the swab in her nostril.Consumer reported a little burning feeling but dissipated after cleaning with water.Although requested, no additional patient information including treatment and outcome was provided.
Additional Manufacturer Narrative
Investigation conclusion: technical service advised the customer to rinse their nose with lots of water and provided the customer with the poison.Org website containing poison control numbers should they experience additional symptoms.According to the package insert in195150c v.3.0: a.Prepare for the test.3.Remove dropper bottle cap.Hold dropper bottle straight over top hole, not at an angle.Put 6 drops into top hole.Do not touch card with tip.B.Collect nasal sample.4.Open swab package at stick end.Take swab out.5.Swab both nostrils carefully as shown.Insert the entire soft tip of the swab into a nostril (usually 1/2 to 3/4 of an inch).You do not need to go deeper.Using medium pressure, rub the swab against all of the inside walls of your nostril.Make at least 5 big circles.Do not just spin the swab.Each nostril must be swabbed for about 15 seconds.Using the same swab, repeat step 5 in your other nostril.Precautions: 20.The reagent solution contains a harmful chemical (see table below).If the solution contacts the skin or eye, flush with copious amounts of water.If irritation persists, seek medical advice: https://www.Poison.Org/contact-us or 1-800-222-1222.Based on the above summary the investigation is deemed complete.The product will continue to be monitored and tracked.

• Brand Name: BINAXNOW COVID-19 ANTIGEN SELF-TEST
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough,; ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough,
• MDR Report Key: 15074464
• Report Number: 1221359-2022-03624
• Device Sequence Number: 5489538
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: 01008118770113301721111310148985
• 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): 08/03/2022

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 Catalogue Number: 195-160
• Device Lot Number: 148985
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White