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 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

Fda udi ¿ (b)(4).Exp.Date - 13may2024.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 213266 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 213266 and test base part number 195-430wl/ lot 210894.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 213266 showed that the complaint rate is (b)(4)%.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 213266 showed that the complaint rate is (b)(4).Fda udi - (b)(4).Exp.Date - 19jul2024.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 219409 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 219409 and test base part number 195-430h / lot 217292.The lot met the required release specifications.A review of the complaints reported as false positive or false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 219409 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 have possibly been related to user technique or the specific patient sample.H3 other text : single-use: device discarded.

Event Description

The consumer reported conflicting results with a binaxnow covid-19 antigen self-test on (b)(6) 2023 on a nasal sample using two different lot numbers.The first test performed with lot 213266 generated a negative result.The consumer considered this result to be inaccurate as they were symptomatic for a few days prior to taking the first test.The second test, performed with lot 219409, was performed later the same day and generated a positive result.Confirmation testing was not performed.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 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: 17916074
• MDR Text Key: 325452870
• Report Number: 1221359-2023-01539
• 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
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2023
• 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 Sex: Male