MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC BINAXNOW COVID-19 HOME TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number	195-100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false negative result with the binaxnow covid-19 home test performed on (b)(6) 2021 on a direct tested nasal kitted swab.The initial test performed on (b)(6) 2021 generated negative results.Repeat testing was performed on (b)(6) 2021 generating negative results.Confirmation testing was performed on (b)(6) 2021 generating positive results.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
The investigation is still in progress.A supplemental report will be provided after completion.
Additional Manufacturer Narrative
Investigation: testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 139811h 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 195-200 / lot 139811h and device part number 195-430h / lot 135690.The lot met the required release specifications.A review of the complaints reported as xxxxxxxx patient results (confirmed and unconfirmed, conflicting results) related to kit lot 139811h showed that the complaint rate is (b)(4).In abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue however a possible assignable root cause is related to the particular samples.

• Brand Name: BINAXNOW COVID-19 HOME TEST
• 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: 13041634
• Report Number: 1221359-2021-03844
• Device Sequence Number: 5423750
• Product Code: QKP
• UDI-Device Identifier: 10811877011337
• UDI-Public: 01108118770113371721091910139811H
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EUA203107
• 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
• Report Date (Section B): 04/14/2022

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: 09/19/2021
• Device Catalogue Number: 195-100
• Device Lot Number: 139811H
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2021
• 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