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 No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2024

Event Type  malfunction  

Event Description

The consumer reported accidental reagent exposure to her eye with a binaxnow covid-19 antigen self-test on (b)(6) 2024.Per the consumer, she accidentally spilled some of the drops of the reagent liquid into her eyes.The consumer confirmed she was not having any irritation or burning sensation, but it was a little bit itchy.Consumer did not require any further medical intervention and there was no reported patient impact.The consumer confirmed there was no death or serious injury.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.Single use; device discarded.

Event Description

The consumer reported accidental reagent exposure to her eye with a binaxnow covid-19 antigen self-test on (b)(6) 2024.Per the consumer, she accidentally spilled some of the drops of the reagent liquid into her eyes.The consumer confirmed she was not having any irritation or burning sensation, but it was a little bit itchy.Consumer did not require any further medical intervention and there was no reported patient impact.The consumer confirmed there was no death or serious injury.No additional information was provided.

Manufacturer Narrative

Fda udi - (b)(4).A product deficiency was not reported or found.Technical services advised the consumer to contact their health provider if any irritation occurred.Technical services was unable to send the consumer the reagent safety data sheet as the consumer did not provide any other contact information.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.

• 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: 18922092
• MDR Text Key: 337881390
• Report Number: 1221359-2024-00273
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081724100510235437
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Device Lot Number: 235437
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2024
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White