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 Fumes or Vapors (2529)

Patient Problem Skin Burning Sensation (4540)

Event Date 09/27/2022

Event Type  Injury  

Event Description

The consumer reported on having chemical smell in entire her niece's house with binaxnow covid-19 ag self-test on (b)(6) 2022.The consumer had a burning sensation on her face when she opened the binax now antigen test.Per consumer, she called the fire department, and was told that she was experiencing irritant.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

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

Event Description

The consumer reported on having chemical smell in entire her niece's house with binaxnow covid-19 ag self-test on (b)(6) 2022.The consumer had a burning sensation on her face when she opened the binax now antigen test.Per consumer, she called the fire department, and was told that she was experiencing irritant.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

The information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend/unexpected performance at the lot and product family level.Customer was provided the relevant sds.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.H3 other text : device discarded, single use.

• 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: 15659775
• MDR Text Key: 302333084
• Report Number: 1221359-2022-10022
• Device Sequence Number: 1
• Product Code: QKP
• 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: 12/21/2022

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 Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 12/21/2022
• 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: 35 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American