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

Catalog Number	195-100
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.
Event or Problem Description
The consumer reported conflicting results with two binaxnow covid-19 home tests performed.The first test generated a positive result.The repeat test generated a negative result.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.
Event or Problem Description
The consumer reported conflicting results with two binaxnow covid-19 home tests performed.The first test generated a positive result.The repeat test generated a negative result.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 148660 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 195-100/195-200/ lot 148660 and device part number 195-430h / lot 143676.Quality control release testing met specifications and there were no conflicting results observed.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).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).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.Based on the above summary, the investigation is deemed complete.

• Brand Name: BINAXNOW COVID-19 AG CARD 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: 13429289
• Report Number: 1221359-2022-00621
• Device Sequence Number: 5354122
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: 01008118770113301721110510148660
• 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): 06/06/2022

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: 11/05/2021
• Device Catalogue Number: 195-100
• Device Lot Number: 148660
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2021
• 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