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 Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/20/2023

Event Type  Injury  

Manufacturer Narrative

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 reagent exposed to her nostril area with the binax now antigen self-test performed on (b)(6) 2023 on a nasopharyngeal swab.The consumer added reagent to the test-card and then inserted the nasal swab.The consumer remembered that they had not swabbed their nostril, so the swab was removed from the test-card and used to swab the nostril for sample collection.The consumer confirmed there was no patient harm or allergies due to the exposure of reagent.Due primary care was taken by the patient.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

Event Description

The consumer reported reagent exposed to her nostril area with the binax now antigen self-test performed on (b)(6) 2023.The consumer reportedly added the reagent to the test card and then inserted the nasal swab into the test card.Then the consumer remembered that they had not swabbed their nostril, so the swab was removed from the test card and was used to swab the nostril for sample collection.The consumer reportedly rinsed their nostrils with water.The consumer confirmed there was no harm due to the reagent exposure.Additionally, the consumer confirmed there was no delay or impact in their treatment.

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.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.A2, b5, h6 (medical device problem code) 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: 16444233
• MDR Text Key: 310260313
• Report Number: 1221359-2023-00408
• 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: 05/07/2023

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: 05/14/2024
• Device Catalogue Number: 195-160
• Device Lot Number: 212595
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/07/2023
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White