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 10/05/2023

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 : other - device not returned; single use device.

Event Description

The consumer reported conflicting results with the binaxnow covid-19 self-test performed on (b)(6) 2023.The consumer initially tested positive with two (2) binaxnow covid-19 self-tests.The consumer performed a third test with the binaxnow covid-19 self-test generating a negative result.The consumer confirmed there was no treatment performed as a result of the test results.No additional information was provided.

Event Description

The consumer reported conflicting results with the binaxnow covid-19 self-test performed on (b)(6) 2023.The consumer initially tested positive with two (2) binaxnow covid-19 self-tests.The consumer performed a third test with the binaxnow covid-19 self-test generating a negative result.The consumer confirmed there was no treatment performed as a result of the test results.No additional information was provided.

Manufacturer Narrative

D4: (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 225186 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 225186 and device part number 195-430h / lot 220868.The lot met the required release specifications.The current overall incident rate for false positive patient results (confirmed and unconfirmed, conflicting results) for lot 225186 based on the total quantity of devices distributed is (b)(4).The current overall incident rate for false negative patient results (confirmed and unconfirmed, conflicting results) for lot 225186 based on the total quantity of devices distributed is (b)(4) in conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however it could have possibly been related to the specific patient sample.Other - device not returned; single use device.

• 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: 17977300
• MDR Text Key: 326193795
• Report Number: 1221359-2023-01563
• 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: 11/16/2023

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: 225186
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 11/16/2023
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White