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 Non Reproducible Results (4029)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

Fda udi ¿ (b)(4).Per product insert, test results should be read between 15-30 minutes.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 conflicting results between the 15-30 minutes read window with a binaxnow covid-19 antigen self-test performed on (b)(6) 2024 on a nasal sample.The test result at 15 minutes was negative.The test result at 17 minutes (two minutes later with the same test) was positive.Repeat testing was not performed.Confirmation testing was not performed.The consumer confirmed there was no harm due to the test result.Additionally, the consumer confirmed there was no delay or impact in their treatment.

Manufacturer Narrative

Fda udi ¿ (b)(4).Per product insert, test results should be read between 15-30 minutes.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 225421 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 225421 and test base part number 195-430wjr / lot 222082.The lot met the required release specifications.A review of the complaints reported false positive and false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 225421 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however they could possibly be related to self-test user performance, result interpretation or the specific patient sample.H3 other text : single use; device discarded.

Event Description

The consumer reported conflicting results between the 15-30 minutes read window with a binaxnow covid-19 antigen self-test performed on (b)(6) 2024 on a nasal sample.The test result at 15 minutes was negative.The test result at 17 minutes (two minutes later with the same test) was positive.Repeat testing was not performed.Confirmation testing was not performed.The consumer confirmed there was no harm due to the test result.Additionally, the consumer confirmed there was no delay or impact in their treatment.

• 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: 18774976
• MDR Text Key: 336192033
• Report Number: 1221359-2024-00218
• 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: 03/14/2024

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: 225421
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/25/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 56 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Hispanic
• Patient Race: White