MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 10CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number	195-170
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: the date provided is an approximation as the exact event date was not provided the remainder of the investigation remains in progress.A supplemental report will be provided after completion.
Event or Problem Description
The consumer reported false negative results with the binaxnow covid-19 antigen self-test kit for five (5) tests performed on or before (b)(6) 2024.This mfr.Report addresses test one (1) of five (5).The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed on or before (b)(6) 2024 on a nasal sample.Repeat testing was performed on the same day which generated a positive result.No additional information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
B3: the date provided is an approximation as the exact event date was not provided testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 870985a 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 195-170/ lot: 870985a, test base part number 195-430wjr/ lot: 870985.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 870985 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 have possibly been related to the patient sample.
Event or Problem Description
The consumer reported false negative results with the binaxnow covid-19 antigen self-test kit for five (5) tests performed on or before (b)(6) 2024.This mfr.Report addresses test one (1) of five (5).The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed on or before (b)(6) 2024 on a nasal sample.Repeat testing was performed on the same day which generated a positive result.No additional information, including treatment and outcome, was provided.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 10CT
• 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: 20007765
• Report Number: 1221359-2024-00559
• Device Sequence Number: 15244756
• Product Code: QKP
• UDI-Device Identifier: 00811877011118
• UDI-Public: 01008118770111181726011210870985A
• 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): 10/16/2024

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: 01/12/2026
• Device Catalogue Number: 195-170
• Device Lot Number: 870985A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• 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 Age: 11 YR
• Patient Sex: Male
• Patient Weight: 45 KG
• Patient Race: White