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 Problems False Positive Result (1227); Non Reproducible Results (4029)

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

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

D4: udi: (b)(4) the remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.Single use; device discarded.

Event Description

The consumer reported conflicting results with the binaxnow covid-19 antigen self-test performed on (b)(6) 2023 using tests from the same lot.The consumer stated the first test generated a positive result and the second test generated a negative result.No other testing was performed.The consumer was asymptomatic and confirmed there was no delay or impact to treatment and no harm due to the test result.

Manufacturer Narrative

D4: udi: (b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.Please see correction to h6: medical device problem code h3 other text : single use; device discarded.

Event Description

The consumer reported conflicting results with the binaxnow covid-19 antigen self-test performed on 13nov2023 using tests from the same lot.The consumer stated the first test generated a positive result and the second test generated a negative result.No other testing was performed.The consumer was asymptomatic and confirmed there was no delay or impact to treatment and no harm due to the test result.

Manufacturer Narrative

D4: udi: (b)(4), testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 221368 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 221368, test base part number 195-430h / lot 217320.The lot met the required release specifications.A review of the complaints reported as false positive and false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 221368 showed that the complaint rate is (b)(4) respectively.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however it could have possibly been related to issues including the self-test user performance, interpretation of the result, or the specific patient sample.H3 other text : single use; device discarded.

Event Description

The consumer reported conflicting results with the binaxnow covid-19 antigen self-test performed on (b)(6) 2023 using tests from the same lot.The consumer stated the first test generated a positive result and the second test generated a negative result.No other testing was performed.The consumer was asymptomatic and confirmed there was no delay or impact to treatment and no harm due to the test result.

• 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: 18160767
• MDR Text Key: 328414308
• Report Number: 1221359-2023-01668
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• 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: 221368
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2024
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White