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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.

Event Description

The consumer reported accidental exposure to the binaxnow covid-19 antigen self-test extraction reagent on 01apr2024.The consumer accidentally mistook the reagent for eye drops.The consumer is doing fine and had no irritation or any other injury due to reagent exposure.The consumer stated the patient was asymptomatic.No additional information including treatment and outcome was provided.

Event Description

The consumer reported accidental exposure to the binaxnow covid-19 antigen self-test extraction reagent on (b)(6) 2024.The consumer accidentally mistook the reagent for eye drops.The consumer is doing fine and had no irritation or any other injury due to reagent exposure.The consumer stated the patient was asymptomatic.The customer confirmed there was no patient harm due to the test results.No additional information including treatment and outcome was provided.

Manufacturer Narrative

A product deficiency was not reported or found.Technical service provided the safety data sheet and advised the consumer to contact their health provider if any irritation occurred.The reported health status 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.

• 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: 19068774
• MDR Text Key: 339667650
• Report Number: 1221359-2024-00331
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081723063010200252
• 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: 04/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2024
• Device Catalogue Number: 195-160
• Device Lot Number: 200252
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/14/2024
• 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 Sex: Female