MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 4CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number	195-180
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: the date of event is an estimation as the actual event date was not provided.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 898557a 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 195-180 / lot 898557a, device part number 195-430wjr/ lot 898557.The lot met the required release specifications.A review of the complaints reported as false positive and/or false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 898557 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue, however, it could possibly be related to self-test user performance or the specific patient sample.
Event or Problem Description
The consumer reported a false negative result with the binaxnow covid-19 ag self test performed at an unknown date.This report is for user one (1) of two (2).The consumer reported a false negative result with the binaxnow covid-19 ag self test performed at an unknown date.The consumer visited her healthcare provider and received a positive result with a dual test for flu/covid (brand and date of test unknown).The consumer noted having symptoms, but specific symptoms were not provided.The consumer mentioned being in good health and managing her covid.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
B3: the date of event is an estimation as the actual event date was not provided.The results of the investigation are still pending.A supplemental report will be submitted upon completion or upon receipt of additional information.
Event or Problem Description
The consumer reported a false negative result with the binaxnow covid-19 ag self test performed at an unknown date.This report is for user one (1) of two (2).The consumer reported a false negative result with the binaxnow covid-19 ag self test performed at an unknown date.The consumer visited her healthcare provider and received a positive result with a dual test for flu/covid (brand and date of test unknown).The consumer noted having symptoms, but specific symptoms were not provided.The consumer mentioned being in good health and managing her covid.No additional patient information, including treatment and outcome, was provided.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 4CT
• Common Device Name: 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: 20360723
• Report Number: 1221359-2024-00628
• Device Sequence Number: 7284542
• Product Code: QKP
• UDI-Device Identifier: 00811877011729
• UDI-Public: (01)00811877011729(17)260517(10)898557A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EUA210264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/17/2026
• Device Catalogue Number: 195-180
• Device Lot Number: 898557A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female