MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 10CT; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

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	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer reported seven (7) false negative results with the binaxnow covid-19 ag self test performed on different dates.This mfr.Report addresses test two (2) of seven (7).The consumer reported a false negative result with the binaxnow covid-19 ag self test performed on unknown date with unknown sample type.In the week prior (date unknown) to the negative result, the consumer tested positive using access bio and roche test with unknown sample type.The consumer reported being symptomatic.Although requested, no additional information including patient treatment and outcome was provided.
Additional Manufacturer Narrative
B3: the date indicated is an approximation as the exact event date was not provided.The remainder of the investigation is in progress.A supplemental report will be provided pending completion, or upon receipt of new information.
Additional Manufacturer Narrative
B3: the date indicated is an approximation as the exact event date was not provided.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 0000910212 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 kit part number 195-170/ lot 0000910212 and device part number 195-430wjr/ lot 910212.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 0000910212 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 specific patient sample.
Event or Problem Description
The consumer reported seven (7) false negative results with the binaxnow covid-19 ag self test performed on different dates.This mfr.Report addresses test two (2) of seven (7).The consumer reported a false negative result with the binaxnow covid-19 ag self test performed on unknown date with unknown sample type.In the week prior (date unknown) to the negative result, the consumer tested positive using access bio and roche test with unknown sample type.The consumer reported being symptomatic.Although requested, no additional information including patient treatment and outcome was provided.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 10CT
• Common Device Name: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• 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: 21154326
• Report Number: 1221359-2025-00008
• Device Sequence Number: 9189629
• Product Code: QKP
• UDI-Device Identifier: 00811877011118
• UDI-Public: 010081187701111817260622100000910
• 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): 03/07/2025

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: 06/22/2026
• Device Catalogue Number: 195-170
• Device Lot Number: 0000910212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2024
• 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