MAUDE Adverse Event Report: ABBOTT BINAX NOW COVID HOME ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problems Use of Device Problem (1670); Device Markings/Labelling Problem (2911); Patient Device Interaction Problem (4001)

Patient Problems Red Eye(s) (2038); Blurred Vision (2137); Chemical Exposure (2570); Eye Pain (4467)

Event Date 09/17/2022

Event Type  Injury  

Event Description

That morning i had taken a binax now covid home test.The second unused test kit items were on my dresser near my cosmetics and eye drops.I have dry eye and use numerous eye drops, daily.That morning i picked up a vial from the dresser thinking it was my refresh eye drops and put a drop in each eye.They immediately felt like they were on fire.When i could finally see, i realized that i had inadvertently used the covid vial thinking it was an eye drop syringe.My eyes were completely red and my pupils were completely dilated.I called my primary physician and spoke with the on-call dr.He told me to flush my eyes with saline or eye wash.He said he needed to consult with poison control.He called me back and said poison control said to flush as well and contact my ophthalmologist and if the pain didn't subside to go to an emergency room.Poison control then contacted me and reassured me that the "ph" concentration of the chemical ingredient in the covid vial (sodium azide) was so low that i should be okay, ultimately.Since this incident, i have seen my ophthalmologist and been told my blurred vision will eventually correct itself.My corneas are still extremely irritated but that's to be expected.While this incident is totally user error, i just wanted to report it because the vials are, in fact, almost identical in size and shape.I don't know if i am able to attach a photo but when you see the vials next to each other, it's shocking.Perhaps the covid vial could be a different color than eye drops; or never in a vial that looks like an eye drop? other covid home kits have better vials-like "flow flex".No one is going to mistake that test liquid for an eye drop.Fda safety report id# (b)(4).

• Brand Name: BINAX NOW COVID HOME ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 15462345
• MDR Text Key: 300432801
• Report Number: MW5112182
• Device Sequence Number: 1
• 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: Patient
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: RESTAYSIS
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White