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 Problems Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 12/17/2023

Event Type  malfunction  

Manufacturer Narrative

D4-(b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use; device discarded.

Event Description

The consumer reported that their son took a binaxnow covid-19 ag self-test on (b)(6) 2023 but was not aware that the instructions for use were printed on two side of the product insert (pi).As a result of not consulting the entire pi, the consumer indicated that no reagent was added to the test card as required for a valid test.The result of the test showed a negative result and no precautions were taken to avoid covid transmission (masks were not worn and did not quarantine/isolate).The consumer stated that four days later on (b)(6) 2023 that they tested positive for covid-19 and believe that they could have avoided contracting covid-19 if the instructions were printed on one side of the pi so that their son¿s test result would have been accurate.The consumer has a health history of restrictive lung disease, asthma, and bronchitis.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

D4-udi:(b)(4).The user added incorrect number (less than 4 drops) of extraction reagent with their binaxnow covid-19 test.This can lead to an unreliable negative result.An unreliable result shall be considered the final determination.In conclusion, abbott diagnostics scarborough did not identify a product deficiency.The batch history record review (bhr) revealed that the product met acceptance criteria for release, and review of complaint trends against the kit lot for the reported issue indicates the product is performing within expected claims in the current revision of the package insert.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however it could have possibly been related to issues including the self-test user performance as the customer didn't consulting the entire pi to complete the test as required and didn't add reagent drops to the test card.Single use; device discarded.

Event Description

The consumer reported that their son took a binaxnow covid-19 ag self-test on (b)(6) 2023 but was not aware that the instructions for use were printed on two sides of the product insert (pi).As a result of not consulting the entire pi, the consumer indicated that no reagent was added to the test card as required for a valid test.The result of the test showed a negative result and no precautions were taken to avoid covid transmission (masks were not worn and the user did not quarantine/isolate).The consumer stated that four days later on (b)(6) 2023, they tested positive for covid-19 and believe that they could have avoided contracting covid-19 if the instructions were printed on one side of the pi so that their son¿s test result would have been accurate.The consumer has a health history of restrictive lung disease, asthma, and bronchitis.No additional patient information, including treatment and outcome, was provided.

• 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: 18502828
• MDR Text Key: 332778104
• Report Number: 1221359-2024-00052
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/04/2024
• Device Catalogue Number: 195-160
• Device Lot Number: 201331
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2024
• 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