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

Catalog Number 195-160

Device Problem Use of Device Problem (1670)

Patient Problems Eye Burn (2523); Eye Pain (4467)

Event Date 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

Technical service provided the safety data sheet to the customer and no further action is required.According to the package insert in195150c v.3.0.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.

Event Description

The consumer reported exposing his eyes to the extraction reagent of the binaxnow covid-19 antigen self test after mistakenly using the extraction reagent as eye drops.The consumer reported experiencing discomfort and burning sensation.

• Brand Name: BINAXNOW COVID-19 ANTIGEN SELF-TEST
• Type of Device: 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: 15002959
• MDR Text Key: 304691087
• Report Number: 1221359-2022-03582
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other