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 Improper or Incorrect Procedure or Method (2017)

Patient Problem Eye Pain (4467)

Event Date 02/04/2024

Event Type  malfunction  

Manufacturer Narrative

The technical services provided the information regarding the chemical structure of reagent solution.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : device discarded; single-use device.

Event Description

The consumer reported accidental exposure to the binaxnow covid-19 antigen self-test reagent on (b)(6) 2024.Per the consumer, she mistakenly used the reagent as eye drops and added 1-2 drops of the reagent to their eyes.The consumer reported experiencing a burning sensation at first that went away after washing the eyes with water.The consumer confirmed that they had no effects from the reagent.No additional information was provided.

Manufacturer Narrative

A product deficiency was not reported or found.Technical service could not be sent the safety data sheet to the customer directly since they did not provide an email address.The customer was provided with the ingredients for the reagent and the number for poison control if they were to need it, and advised to seek medical assistance if they were to experience any irritation.The reported of reagent contact with eye is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.A supplemental report will be provided if any additional is obtained.H3 other text : device discarded; single-use device.

Event Description

The consumer reported accidental exposure to the binaxnow covid-19 antigen self-test reagent on (b)(6) 2024.Per the consumer, she mistakenly used the reagent as eye drops and added 1-2 drops of the reagent to their eyes.The consumer reported experiencing a burning sensation at first that went away after washing the eyes with water.The consumer confirmed that they had no effects from the reagent.No additional information was provided.

• 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: 18684638
• MDR Text Key: 335114240
• Report Number: 1221359-2024-00165
• 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
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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: 03/05/2024
• 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: 69 YR
• Patient Sex: Female