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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4-udi: (b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use; device discarded.
Event or Problem Description
The consumer reported a false positive result with the binaxnow covid-19 antigen self-test performed on (b)(6) 2023 on an unknown sample type.Repeat testing was performed three (3) times on the same day, each generating a negative result.Three (3) additional tests were performed on the same day using an inteliswab rapid antigen test, an access bio rapid antigen test, and a lucira rapid antigen test, all generating negating results.No additional information, including treatment and outcome, was provided.
Event or Problem Description
The consumer reported a false positive result with the binaxnow covid-19 antigen self-test performed on (b)(6) 2023 on an unknown sample type.Repeat testing was performed three (3) times on the same day, each generating a negative result.Three (3) additional tests were performed on the same day using an inteliswab rapid antigen test, an access bio rapid antigen test, and a lucira rapid antigen test, all generating negating results.No additional information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
D4-udi: (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 235458 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: 235458, test base part number 195-430wl/ lots: 227263a, 227263b, and 227263c.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 235458 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.H3 other text : single use; device discarded.

• 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: 18507942
• Report Number: 1221359-2024-00055
• Device Sequence Number: 7900906
• Product Code: QKP
• UDI-Device Identifier: 00811877011118
• UDI-Public: 00811877011118
• 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): 01/24/2024

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: 10/13/2024
• Device Catalogue Number: 195-170
• Device Lot Number: 235458
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White