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	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the patient had dipped the swab into the reagent prior to inserting the swab in their nostril.Although requested, no additional patient information including treatment and outcome was provided.
Additional Manufacturer Narrative
A product deficiency was not reported or found.Technical service provided the safety data sheet to the customer.Technical service confirmed there was no further information available.A supplemental report will be provided if any additional is obtained.

• 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,
• MDR Report Key: 14550591
• Report Number: 1221359-2022-02820
• Device Sequence Number: 17767844
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: 01008118770113301721100510142802
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 195-100
• Device Lot Number: 142802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male