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 False Positive Result (1227)

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

Event Date 02/17/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The consumer reported a false positive result with the binaxnow covid-19 antigen self-test performed on (b)(6) 2024 on a nasal sample.Initial testing was performed on (b)(6) 2024 using a binaxnow covid-19 antigen self-test which generated a negative result.Additional testing was performed on (b)(6) 2024 via a quickview rapid antigen test which generated a negative result.The consumer indicated they were asymptomatic.The consumer confirmed there was no harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in treatment.

Manufacturer Narrative

D4-udi: (b)(4), testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 227267 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: 227267, test base part number 195-430wjr/ lot: 227267.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 227267 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.H3 other text : single use; device discarded.

Event Description

The consumer reported a false positive result with the binaxnow covid-19 antigen self-test performed on (b)(6) 2024 on a nasal sample.Initial testing was performed on (b)(6) 2024 using a binaxnow covid-19 antigen self-test which generated a negative result.Additional testing was performed on (b)(6) 2024 via a quickview rapid antigen test which generated a negative result.The consumer indicated they were asymptomatic.The consumer confirmed there was no harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in treatment.

Event Description

The consumer reported a false positive result with the binaxnow covid-19 antigen self-test performed on 17feb2024 on a nasal sample.Additional testing was performed on (b)(6)2024 using a binaxnow covid-19 antigen self-test which generated a negative result.Additional testing was performed on 21feb2024 via a quickview rapid antigen test which generated a negative result.The consumer indicated they were symptomatic.The consumer confirmed there was no harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in treatment.

Manufacturer Narrative

Correction: b3: the date of occurrence has been corrected b5: the dates of testing have been corrected and the customer indicated they were symptomatic on 17feb2024.Additional narrative: d4-udi:(b)(4) testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 227267 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: 227267, test base part number 195-430wjr/ lot: 227267.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 227267 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.

• 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: 18902634
• MDR Text Key: 337643018
• Report Number: 1221359-2024-00268
• 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,Followup
• Report Date: 04/05/2024

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: 195-160
• Device Lot Number: 227267
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 03/20/2024; 03/28/2024
• Supplement Dates FDA Received: 03/20/2024; 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2023
• 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