MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD KIT 40T EUA; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number	195-000
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported three (3) false positive results with the binaxnow covid-19 ag test performed on various dates with the same patient.This report is for test two (2) of three (3).The customer reported a false positive result with the binaxnow covid-19 ag test performed on an unknown date.A pcr test was sent to an outside lab (date unknown) where the result was negative.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
B3 - date of event: date of event is an estimation as the dates of the tests taken could not be obtained.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 customer reported three (3) false positive results with the binaxnow covid-19 ag test performed on various dates with the same patient.This report is for test two (2) of three (3).The customer reported a false positive result with the binaxnow covid-19 ag test performed on an unknown date.A pcr test was sent to an outside lab (date unknown) where the result was negative.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
B3 - date of event: date of event is an estimation as the dates of the tests taken could not be obtained.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 869108y 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 195-000 / lot 869108y and device part number 195-430wjr / lot 869108.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 869108y 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.

• Brand Name: BINAX NOW COVID-19 AG CARD KIT 40T EUA
• 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: 20747029
• Report Number: 1221359-2024-00675
• Device Sequence Number: 8363027
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: (01)10811877011290(17)260112(10)869108Y
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EUA202537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: Health Professional
• Device Expiration Date: 01/12/2026
• Device Catalogue Number: 195-000
• Device Lot Number: 869108Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• 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