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 Device Handling Problem (3265)

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

Event Date 11/21/2022

Event Type  Injury  

Event Description

The consumer reported that the reagent from the binaxnow covid-19 ag self-test came into contact with their lips.The consumer indicated that they were not feeling any effects from being exposed to the reagent.No additional information was reported.

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.Single use device, discarded.

Manufacturer Narrative

Investigation summary: a product deficiency was not identified.Abbott technical services provide the consumer with the safety data sheet for the binaxnow covid-19 ag self-test.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card.D4-expiration date.H3 other text : single use device, discarded.

Event Description

The consumer reported that the reagent from the binaxnow covid-19 ag self-test came into contact with their lips.The consumer indicated that they were not feeling any effects from being exposed 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: 15870875
• MDR Text Key: 304375302
• Report Number: 1221359-2022-10193
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: 195-160
• Device Lot Number: 211610
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2023
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 50 KG