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 03/29/2023

Event Type  malfunction  

Event Description

The consumer reported accidental exposure to the eye with the binaxnow covid-19 antigen self-test reagent.Per the patient, one drop of the reagent fell into his eye, which led to eye pain.The consumer reportedly washed their eye.No additional information was provided.

Manufacturer Narrative

The consumer was stated they had no further questions and was transferred to poison control.The remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.Single-use; device discarded.

Event Description

The consumer reported accidental exposure to the eye with the binaxnow covid-19 antigen self-test reagent.Per the patient, one drop of the reagent fell into his eye, which led to eye pain.The consumer reportedly washed their eye.No additional information was provided.

Manufacturer Narrative

The consumer was stated they were satisfied with the information provided and had no further questions.Additionally, the consumer was transferred to poison control.A product deficiency was not reported or found.Technical service was unable to provide the reagent safety data sheet to the consumer as an email address was not provided.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.

• 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: 16683885
• MDR Text Key: 312857960
• Report Number: 1221359-2023-00581
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/29/2023
• Device Catalogue Number: 195-160
• Device Lot Number: 189982
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 145 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White