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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer reported false positive results with the binaxnow covid-19 antigen self-test performed on two dates using two lots with the kit swab and a nasal sample.This mfr.Report addresses test one (1) of two (2).The consumer reported taking the test on (b)(6) 2022 and getting a faint sample line (positive), but had isolated for two weeks with no symptoms.Confirmation testing was performed the same day using an ihealth test and generated a negative result.The customer confirmed there was no impact or treatment done.
Additional Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Please reference all related mfr.Report numbers: 1221359-2022-03421.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the investigation conclusion.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 180685 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- 100 / lot 180685 and device part number 195-430h / lot 178467.The lot met the required release specifications.The current overall incident rate for false positive patient results (confirmed and unconfirmed, conflicting results) for this specific lot based on the total quantity of devices manufactured for distribution is (b)(4).In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue however a possible assignable root cause is patient sample interference.Substances in the sample itself may have interfered with the reaction.A review of complaints against the kit lot for the reported issue indicates product performance is as expected and a product deficiency has not been identified.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the corrected information for the investigation conclusion.The information submitted under supplemental report one (1) was for mfr report number 1221359-2022-03421, but was inadvertently submitted under 1221359-2022-03420.Corrected fields and investigation conclusion: testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 172637 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 / 195-260 / lot 172637 and device part number 195-430h / lot 164557.The lot met the required release specifications.The current overall incident rate for false positive patient results (confirmed and unconfirmed, conflicting results) for this specific lot based on the total quantity of devices manufactured for distribution is (b)(4).In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue however a possible assignable root cause is patient sample interference.Substances in the sample itself may have interfered with the reaction.A review of complaints against the kit lot for the reported issue indicates product performance is as expected and a product deficiency has not been identified.

• 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: rachel blackwell ; 10 southgate road; scarborough,
• MDR Report Key: 15005804
• Report Number: 1221359-2022-03420
• Device Sequence Number: 11392359
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: 01008118770113301722112110175450A
• 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,Followup
• Report Date (Section B): 08/08/2022

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: 09/11/2022
• Device Catalogue Number: 195-160
• Device Lot Number: 172637
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 07/18/2022; 07/18/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/04/2022; 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2021
• 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: Male