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 Problems Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

Patient Problem Red Eye(s) (2038)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

The consumer reported an accidental reagent exposure to the eyes with a binaxnow covid-19 antigen self-test on (b)(6).2023.Per the consumer, she accidently put reagent into her eyes as she was opening the bottle of the reagent.The consumer had mistakenly used the reagent solution as her eye drops.Consumer stated her eyes became red after flushing with water.Consumer also stated she was not having any irritation and was fine after the exposure and did not require any further medical intervention.There was no reported patient impact.No additional information was provided.

Manufacturer Narrative

Fda udi ¿ (b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use; device discarded.

Manufacturer Narrative

Fda udi ¿ (b)(4).A product deficiency was not reported or found.Technical service provided the safety data sheet.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.H3 other text : single use; device discarded.

Event Description

The consumer reported an accidental reagent exposure to the eyes with a binaxnow covid-19 antigen self-test on (b)(6) 2023.The consumer mistakenly used the reagent solution as her eye drops.Consumer stated her eyes became red after flushing with water.Consumer also stated she was not having any irritation and was fine after the exposure and did not require any further medical intervention.There was no reported patient impact.No additional information was provided.

Event Description

The consumer reported an accidental reagent exposure to the eyes with a binaxnow covid-19 antigen self-test on (b)(6) 2023.The consumer mistakenly used the reagent solution as her eye drops.Consumer stated her eyes became red after flushing with water.Consumer also stated she was not having any irritation and was fine after the exposure and did not require any further medical intervention.There was no reported patient impact.No additional information was provided.

Manufacturer Narrative

Fda udi ¿ (b)(4) the remainder of the investigation remains in progress.A supplemental report will be provided after completion.B5 h-6: medical device problem code h3 other text : single use; device discarded.

• 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: 18463032
• MDR Text Key: 332381521
• Report Number: 1221359-2024-00034
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 00811877011408
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/10/2023
• Device Catalogue Number: 195-160
• Device Lot Number: 186913
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2024
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White