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 Red Eye(s) (2038)

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

D4 udi: (b)(4).The investigation remains in progress.A supplemental report will be provided after completion.Abbot technical services emailed a copy of the safety data sheet to the consumer for their records.H3 other text : single use; device discarded.

Event Description

The consumer reported adding reagent drops from the binaxnow covid-19 antigen self-test to their eyes on (b)(6) 2023 after mistaking it for their non-prescription eye drop bottle.The consumer reported having redness on their left eye after washing with water.The consumer confirmed there was no harm caused by the accidental exposure to the reagent.No additional information was reported.

Manufacturer Narrative

D4 udi: (b)(4).A product deficiency was not reported or found.Technical service provided the safety data sheet to the customer.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 adding reagent drops from the binaxnow covid-19 antigen self-test to their eyes on (b)(6)2023 after mistaking it for their non-prescription eye drop bottle.The consumer reported having redness on their left eye after washing with water.The consumer confirmed there was no harm caused by the accidental exposure to the reagent.No additional information was reported.

• 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: 17858477
• MDR Text Key: 324780948
• Report Number: 1221359-2023-01475
• 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: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• 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: 223000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2023
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 64 KG