MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC BINAXNOW COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number	195-160
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation is still in progress.Once the investigation is complete a supplemental report will be provided.
Event or Problem Description
The consumer reported an unconfirmed false negative result with the binaxnow covid-19 antigen self test.The customer also reported a vertical red line by the swab area.The consumer confirmed that the patient is symptomatic.No additional patient information, including patient out come was provided.
Additional Manufacturer Narrative
Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 153670 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 195-160 / lot: 153670 , test base part number 195-430h / lot: 153670.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 153670 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue; however, it could possibly be related to issues including the self-test user performance, interpretation of the result, or the specific patient sample.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide corrected data and additional information.

• Brand Name: BINAXNOW COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK
• 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: 11900250
• Report Number: 1221359-2021-01580
• Device Sequence Number: 17062668
• Product Code: QKP
• UDI-Device Identifier: 00811877011415
• UDI-Public: 01008118770114151721120210153670
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2022

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: 12/02/2021
• Device Catalogue Number: 195-160
• Device Lot Number: 153670
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 11/03/2021; 11/03/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 11/22/2021; 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2021
• 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: Unknown