MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD KIT 40T EUA; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number 195-000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Red Eye(s) (2038)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The customer reported that her employee had an accidental exposure to the binax now covid-19 ag card reagent on (b)(6)2023.Per the customer, her employee had performed the test earlier that day and had put the reagent bottle in her pocket.Later that day, she accidentally mistook the reagent for eye drops and added one (1) drop into one (1) eye before realizing her mistake.The customer reported that her employee experienced a burning sensation in her eye before flushing the eye with water at their eye-wash station.She additionally reported that the employee's eye was red after utilizing the eye-wash station but that she was no longer experiencing any burning at the time of the call.The technical service agent was able to gather the customer's employee's contact information and email the binaxnow covid-19 reagent safety data sheet.

Manufacturer Narrative

Technical services provided the safety data sheet to the customer.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.

Event Description

The customer reported that her employee had an accidental exposure to the binax now covid-19 ag card reagent on (b)(6) 2023.Per the customer, her employee had performed the test earlier that day and had put the reagent bottle in her pocket.Later that day, she accidentally mistook the reagent for eye drops and added one (1) drop into one (1) eye before realizing her mistake.The customer reported that her employee experienced a burning sensation in her eye before flushing the eye with water at their eye-wash station.She additionally reported that the employee's eye was red after utilizing the eye-wash station but that she was no longer experiencing any burning at the time of the call.The technical service agent was able to gather the customer's employee's contact information and email the binaxnow covid-19 reagent safety data sheet.

Manufacturer Narrative

A product deficiency was not reported or found.Technical service provided the safety data sheet to the customer.A supplemental report will be provided if any additional information is obtained.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.

• Brand Name: BINAX NOW COVID-19 AG CARD KIT 40T EUA
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 17474520
• MDR Text Key: 320571299
• Report Number: 1221359-2023-01318
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 10811877011290
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 195-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White