MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH INC. BINAX NOW 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 Date 12/28/2020

Event Type  Injury  

Manufacturer Narrative

No additional information, evaluation or clarification of data is applicable.The reported event in nature and severity for binaxnow covid-19 ag card are captured within the product's risk management file.No further action is required.

Event Description

A customer reported accidentally using the binaxnow covid-19 ag extraction reagent solution in their eye on (b)(6) 2020.The customer reported that he had slightly blurry vision and burning in the eye on the day of the event.The customer had an eye exam on (b)(6) 2020, where his physician provided tobradex eyedrops for the mild irritation.The customer was to have a follow-up session with the physician and was advised to inform if the issue did not resolve.There has been no additional communication from the customer.The customer was provided with the safety data sheet for the binaxnow covid-19 ag card reagent solution.No additional information has been provided.The extraction reagent packaged in this kit contains saline, detergents and sodium azide, preservatives that will inactivate cells and virus particles.Samples eluted in this solution are not suitable for culture.Although the volume is too low to likely cause serious adverse events, due to the ingredients of the reagent and the sensitive nature of the eye, there is moderate risk of serious injury to the eye.Therefore, the incident shall be considered reportable.

• Brand Name: BINAX NOW COVID-19 AG CARD
• Type of Device: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: alexa wakley ; 10 southgate road; scarborough, ME 04074 ; 2077305750
• MDR Report Key: 11219361
• MDR Text Key: 230926423
• Report Number: 1221359-2021-00195
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2021

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: No Information
• Device Catalogue Number: 195-000
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other