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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The remainder of the investigation is in progress.A supplemental report will be provided pending completion, or upon receipt of new information.
Event or Problem Description
The consumer reported multiple false positive results with the binaxnow covid-19 ag self test performed on various dates.This mfr.Report is four (4) of 4 (four).The consumer reported a false positive result with the binaxnow covid-19 ag self test performed on (b)(6) 2024 with nasal sample type.Additional testing was performed using flow flex test with unknow sample type on (b)(6) 2024 which gave negative result.The consumer confirmed that she was asymptomatic and no patient harm due to the test results.
Event or Problem Description
The consumer reported multiple false positive results with the binaxnow covid-19 ag self test performed on various dates.This mfr.Report is four (4) of 4 (four).The consumer reported a false positive result with the binaxnow covid-19 ag self test performed on (b)(6) 2024 with nasal sample type.Additional testing was performed using flow flex test with unknow sample type on (b)(6) 2024 which gave negative result.The consumer confirmed that she was asymptomatic and no patient harm due to the test results.
Additional Manufacturer Narrative
Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 870972b 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 870972b and device part number 195-430wjr/ lot 870972.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 870972 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.

• 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: 20388113
• Report Number: 1221359-2024-00637
• Device Sequence Number: 6548783
• Product Code: QKP
• UDI-Device Identifier: 00811877011118
• UDI-Public: 01008118770111181726011210870972B
• 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): 10/23/2024

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: 870972B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2024
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White