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); Eye Burn (2523)

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

A product deficiency was not reported or found.The customer was provided with the reagent safety data sheet (sds).

Event Description

The customer reported that a nurse in the department accidently put the binaxnow covid-19 reagent in both eyes while driving, instead of grabbing the allergy eye drops from her purse.Per the nurse she believes she inadvertently "threw" the reagent bottle in her purse instead of the garbage thinking it was her allergy eye drops as she had just opened another box of test kits.The customer reported that the nurse immediately flushed her eyes with a water bottle she had in the car.This was prior to calling for assistance.The nurse reported blurry vision and being unable to see anything.The nurse was evaluated by an opthomologist and was found to have chemical burns in both eyes.As treatment an amoeba membrane was placed on the nurse's eye and steroid/antibiotic drops were prescribed.A follow up appointment was scheduled for the next day with the opthomologist to remove the amoeba membrane and place it on the second eye.The nurse was noted to have a milky film over both eyes with cloudy vision; however, the nurse's is able to see some.The customer reported that the nurse was instructed to keep her eyes close for the day.

• 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: erina marshall ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 11942318
• MDR Text Key: 254372285
• Report Number: 1221359-2021-01659
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 01108118770112901721041410129705
• 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,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 195-000
• Device Lot Number: 129705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2021
• 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; Required Intervention