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 No Apparent Adverse Event (3189)

Patient Problem Skin Burning Sensation (4540)

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

D4: udi- (b)(4).The technical services provided the information regarding the chemical structure of reagent solution.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : device discarded; single-use device.

Event Description

The consumer reported accidental exposure to the binaxnow covid-19 antigen self-test reagent on (b)(6) 2024.Per the consumer, she has been exposed to the reagent solution through the cut on her hand.The consumer reported experiencing a burning sensation at first that went away after washing the cut on her hand with water.The consumer confirmed that they had no effects from the reagent.No additional information was provided.

Event Description

The consumer reported accidental exposure to the binaxnow covid-19 antigen self-test reagent on (b)(6)2024.Per the consumer, she has been exposed to the reagent solution through the cut on her hand.The consumer reported experiencing a burning sensation at first that went away after washing the cut on her hand with water.The consumer confirmed that they had no effects from the reagent.No additional information was provided.

Manufacturer Narrative

D4: udi-(b)(4) a product deficiency was not reported or found.Technical service provided the safety data sheet.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.H3 other text : device discarded; single-use device.

• 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: 18704293
• MDR Text Key: 335412573
• Report Number: 1221359-2024-00181
• 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: 02/23/2024

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 Catalogue Number: 195-160
• Device Lot Number: 228743A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White