MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC BINAXNOW COVID-19 ANTIGEN SELF TEST; 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.A supplemental report will be provided after completion.
Event or Problem Description
The user reported a false negative result with the id binaxnow covid-19 antigen self test.The user reported that their initial binaxnow covid-19 antigen self test result was negative.Repeat testing with binaxnow covid-19 self test generated positive results.Confirmation testing with pcr generated 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.
Event or Problem Description
The user reported a false negative result with the id binaxnow covid-19 antigen self test.The user reported that their initial binaxnow covid-19 antigen self test result was negative.Repeat testing with binaxnow covid-19 self test generated positive results.Confirmation testing with pcr generated positive results.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the investigation conclusion.Please see updates: d4, g3, g6, h2, h4 and h6.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 175116 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 195-160/195-260 / lot 175116 and device part number 195-430h / lot 171772.The lot met the required release specifications.The current overall incident rate for false negative patient results (confirmed and unconfirmed, conflicting results) for this specific lot based on the total quantity of devices manufactured for distribution is (b)(4)%.The retain kit lot 175116 was tested with covid-19 lod and blank patient swabs.All tests were run in triplicate, were valid, and performed as expected.No false negative results were observed, and the customers complaint was not replicated.Abbott diagnostics scarborough was unable to determine an assignable root cause, however, a possible assignable root cause is patient sample interference.Substances in the sample itself may have interfered with the reaction.

• Brand Name: BINAXNOW COVID-19 ANTIGEN SELF 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: kindra sudduth ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 13477159
• Report Number: 1221359-2022-00797
• Device Sequence Number: 14799572
• Product Code: QKP
• UDI-Device Identifier: 00811877011415
• UDI-Public: 01008118770114151722101310175116
• 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
• Report Date (Section B): 06/13/2022

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: 01/13/2023
• Device Catalogue Number: 195-160
• Device Lot Number: 175116
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2021
• 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: Female