MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCABOROUGH BINAXNOW COVID-19 AG CARD; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195-000

Device Problem Use of Device Problem (1670)

Patient Problems Blurred Vision (2137); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The user reported accidentally using the reagent as eyedrops.The user was advised to immediately flush eyes with water for 15 minutes.No additional information was provided.

Manufacturer Narrative

Corrected data : b5, g3, e3, h2.

Event Description

The user reported accidentally using the reagent as eyedrops.Per user, eye was irritated.The user was advised to immediately flush eyes with water for 15 minutes.

Manufacturer Narrative

This supplemental report is being submitted to provide the investigation conclusion.Technical service provided the safety data sheet to the customer.According to the package insert in195000 v 3.0 precautions the extraction reagent packaged in this kit contains saline, detergents and preservations that will inactivate cells and virus particles.Samples eluted in this solution are not suitable for culture.The product will continue to be monitored and tracked.

• Brand Name: BINAXNOW COVID-19 AG CARD
• Type of Device: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCABOROUGH; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: kindra sudduth ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 12849934
• MDR Text Key: 281930878
• Report Number: 1221359-2021-03362
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2022

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 Operator: Lay User/Patient
• Device Catalogue Number: 195-000
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/21/2021
• Supplement Dates Manufacturer Received: 02/15/2022; 04/19/2022
• Supplement Dates FDA Received: 03/10/2022; 05/05/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female