MAUDE Adverse Event Report: ABBOTT BINAXNOW COVID-19 ANTIGEN SELF TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 158078

Device Problems Component Missing (2306); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2021

Event Type  malfunction  

Event Description

Order placed online through (b)(6) (quantity 12 kits, all same lot/exp date) and all same lot number were received.Tests were received without issue, apparent damage and all tamper evident seals in tact.One test was used (b)(6) 2021 and all test items were present; however, when administering the test, it was discovered that one of the reagent bottles was empty.I attempted to check the other reagent bottle, however, the reagent bottles are unit dose (similar to bfs items for albuterol), opaque in color and the user cannot tell if there is liquid by feel when shaking.I opened the second bottle and it was filled sufficiently to use the 6 required drops.I used the second reagent bottle to perform the test.Details on the test are provided below.I contacted abbott (b)(6) 2021 to explain the problem and they indicated that the lot should be eligible for replacement and i should contact (b)(6).I called (b)(6) (b)(6) 2021, and i am awaiting resolution from (b)(6) as of the time of this reporting, as i need to have proper tests available for testing prior to a holiday party and want to ensure this issue is not encountered again if this is a lot-wide problem (still on hold).Abbott binaxnow covid-19 antigen self test ref# 195-160, lot 158078 exp 03-27-2022.Test is available for examination at this time if desired.Fda safety report id# (b)(4).

• Brand Name: BINAXNOW COVID-19 ANTIGEN SELF TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 12960387
• MDR Text Key: 282007371
• Report Number: MW5105890
• 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: 12/06/2021

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: Other
• Device Lot Number: 158078
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2021
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White