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

Catalog Number	195160
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.A supplemental report will be provided after completion.
Event or Problem Description
The customer reported discrepancy results with the add product performed on (b)(6) 2021 on an unknown sample.Although requested no additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
It was initially reported that the customer reported discrepancy results with the binaxnow covid-19 antigen home test.After further review, no discrepancy occurred with the assay.The issue was due to the interpretation of the results.There were no allegation of conflicting result, the customer was provided the wrong information about the process during emed session with a proctor.Therefore the results are not considered conflicting results and this event is not reportable.

• Brand Name: BINAX NOW COVID-19 AG CARD
• 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: erina marshall ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12519103
• Report Number: 1221359-2021-02783
• Device Sequence Number: 4094862
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: 01008118770113301721101510143929
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EUA202537
• 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): 05/20/2022

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: 10/15/2021
• Device Catalogue Number: 195160
• Device Lot Number: 143929
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown