MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 1CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number 195-140

Device Problem False Positive Result (1227)

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

Event Date 03/29/2024

Event Type  malfunction  

Event Description

The consumer reported a false positive result performed with the binaxnow covid-19 antigen self-test on (b)(6) 2024 on a nasal sample.Repeat testing was not performed.Confirmation testing was not performed.The consumer performed an ihealth covid-19 antigen rapid test and an azure antigen rapid home test on (b)(6) 2024, both tests generated negative results.The consumer was asymptomatic on (b)(6) 2024 for her positive result.The consumer confirmed there was no patient harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in their treatment.

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.

Manufacturer Narrative

Corrected data - h4 - device mfg date testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 791938 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 195-140 / lot 791938, test base part number 195-430wl / lot 791938.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 791938 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue; however, it could possibly be related to issues including the self-test user performance, interpretation of the result, or the specific patient sample.

Event Description

The consumer reported a false positive result performed with the binaxnow covid-19 antigen self-test on 29mar2024 on a nasal sample.Repeat testing was not performed.Confirmation testing was not performed.The consumer performed an ihealth covid-19 antigen rapid test and an azure antigen rapid home test on 30mar2024, both tests generated negative results.The consumer was asymptomatic on 29mar2024 for her positive result.The consumer confirmed there was no patient harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in their treatment.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 1CT
• 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: 19081192
• MDR Text Key: 340107924
• Report Number: 1221359-2024-00334
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081725031710791938
• 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: 04/26/2024

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 Catalogue Number: 195-140
• Device Lot Number: 791938
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2024
• 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 Sex: Female