MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number 195-160

Device Problem Use of Device Problem (1670)

Patient Problems Red Eye(s) (2038); Blurred Vision (2137)

Event Date 09/17/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The consumer reported extraction reagent had accidentally been dropped in the eye while using binaxnow covid-19 self-test performed on (b)(6) 2022.Consumer experienced blurred vision, irritated corneas, red eyes and dilated pupil.The consumer confirmed it was a user error and had to see an ophthalmologist twice for preservative free eye wash and advised to use prescription steroid eye drops in both eyes, 3 times a day, for 3 weeks.

Event Description

The consumer reported extraction reagent had accidentally been dropped in the eye while using binaxnow covid-19 self-test performed on (b)(6) 2022.Consumer experienced blurred vision, irritated corneas, red eyes and dilated pupil.The consumer confirmed it was a user error and had to see an ophthalmologist twice for preservative free eye wash and advised to use prescription steroid eye drops in both eyes, 3 times a day, for 3 weeks.

Manufacturer Narrative

Technical services called the customer to gather intake information and provided the customer with the reagent safety data sheet.No additional investigation is necessary as a product deficiency was not identified.B2, h3 other text : device discarded, single use device.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 2CT
• Type of Device: 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, ME 04074 ; 6613888803
• MDR Report Key: 15576853
• MDR Text Key: 301556922
• Report Number: 1221359-2022-10004
• 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,Followup
• Report Date: 12/20/2022

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White