MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ABBOTT BINAXNOW COVID-19 ANTIGEN SELF TEST - A PRODUCT, NOT A DEVICE; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 195-160

Device Problems Labelling, Instructions for Use or Training Problem (1318); Product Quality Problem (1506); Component Missing (2306)

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

Event Date 11/24/2021

Event Type  malfunction  

Event Description

I bought an abbott binaxnow at home antigen self test for covid because i am going to thanksgiving dinner at friends tomorrow, and i want to make sure i am not positive for covid.I read the directions twice before starting the process.The directions are very detailed and explicit, and great emphasis is placed on following them exactly.Everything went fine until i inserted the swab into the card and was to fold it over and seal the card closed for 15 minutes.When i went to seal the card closed by exposing an adhesive strip on the right side of the fold over card, i realized that i couldn't do so.There was no adhesive strip and nothing to peel off to expose one.I placed my cell phone on the right hand side to hold it closed after i folded the card in half and set my timer for 15 minutes.I called the abbott number to report the quality problem but they are only open during business hours.I left a message.Given that the cost of the abbott binaxnow test is about (b)(6) for two tests, i think it should be complete and users should be able to follow the directions - which should match the test kit.My test result was negative.All details are above.Fda safety report id# (b)(4).

• Brand Name: ABBOTT BINAXNOW COVID-19 ANTIGEN SELF TEST - A PRODUCT, NOT A DEVICE
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 12892736
• MDR Text Key: 281580950
• Report Number: MW5105649
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2022
• Device Model Number: 195-160
• Device Lot Number: 168658
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White