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 Contamination (1120)

Patient Problem Nausea (1970)

Event Date 12/29/2022

Event Type  malfunction  

Manufacturer Narrative

Technical services provided the safety data sheet to the customer.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.

Event Description

The consumer reported that the swab from the binaxnow covid-19 ag self-test kit felt sticky and smelled like glue when swabbing their nostril during sample collection.The consumer also reported that a ¿white substance¿ was coming out of her nostril after the swab was removed.The consumer stated she felt symptoms of nausea and wanted to know what medication she could take for the reported nausea.The consumer did not receive any medical attention afterwards.No additional patient information, including outcome, was provided.

Event Description

The consumer reported that the swab from the binaxnow covid-19 ag self-test kit felt sticky and smelled like glue when swabbing their nostril during sample collection.The consumer also reported that a ¿white substance¿ was coming out of her nostril after the swab was removed.The consumer stated she felt symptoms of nausea and wanted to know what medication she could take for the reported nausea.The consumer did not receive any medical attention afterwards.No additional patient information, including outcome, was provided.

Manufacturer Narrative

Technical services provided the safety data sheet to the customer.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 213939 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 195-160 / lot: 213939, test base part number 195-430h / lot: 207636.The lot met the required release specifications.A review of the complaints reported as contaminated / used products (swab) related to kit lot 223939 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, it could possibly be related to the specific patient sample.D4: lot # expiration date extended.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: 16174959
• MDR Text Key: 308494075
• Report Number: 1221359-2023-00094
• 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: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/03/2024
• Device Catalogue Number: 195-160
• Device Lot Number: 213939
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/16/2023
• Supplement Dates Manufacturer Received: 03/11/2023
• Supplement Dates FDA Received: 03/16/2023
• 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 Age: 37 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White