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 Date 10/29/2021

Event Type  Injury  

Event Description

The customer reported that on (b)(6) 2021, an employee of the facility mistakenly used the binaxnow covid-19 ag reagent as their cataract medication.The employee reported their eye "felt as it was on fire" and eye redness.The employee flushed their eyes out with warm water and immediately visited the emergency room for evaluation.The emergency room physician flushed the eye again with water.The er physician stated that there was inflammation but did not note any issue with the pupil.The employee also visited their eye doctor.The optometrist reported that the cornea is fine along with the lens that was placed in the eye.Inflammation was noted.The optometrist also stated "due to all that was done the day before and having the antibiotics steroid and inflammation eye drops for my cataract that was so helpful for this outcome." the customer was provided the msds for the solution.Poison control center was also contacted; however, poison control was unable to provide any information.The employee stated that they will return to the optometrist monday (b)(6) for a recheck because the eye does feel scratchy, maybe dry, throughout the day.However, it is unknown if this is due to being post-surgery or combination of both incidents.The employee has since returned to work and does not report any issue with her vision.Additional information has been requested but has not been provided.

Manufacturer Narrative

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

Manufacturer Narrative

This supplemental report is being submitted to provide the investigation conclusion.Technical service provided the safety data sheet to the customer and no further action is required.In conclusion, product deficiency was not reported or identified.The customer was provided the relevant sds.

• 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: 12880094
• MDR Text Key: 281596700
• Report Number: 1221359-2021-03631
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 195-000
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2022
• 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 Age: 63 YR
• Patient Sex: Female