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)

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

B4: udi (b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : other - device not returned; single use device.

Event Description

Consumer reported reagent exposure to their eyes using binax now covid-19 ag card kit on 11dec2023.The consumer reported accidentally using the reagent as eye drops.The consumer also reported burning sensation in both eyes and sought medical attention after exposure.An ointment was prescribed for the patient's eyes.Following treatment, consumer reported feeling better with no new symptoms.

Event Description

Consumer reported reagent exposure to their eyes using binax now covid-19 ag card kit on (b)(6)2023.The consumer reported accidentally using the reagent as eye drops.The consumer stated the patient used one drop of the reagent on both eyes.The consumer also reported burning sensation in both eyes and sought medical attention after exposure.An ointment was prescribed for the patient's eyes.Following treatment, consumer reported feeling better with no new symptoms.The consumer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

Manufacturer Narrative

D4: udi ((b)(6) a product deficiency was not reported or found.Technical service provided the safety data sheet.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.A supplemental report will be provided if any additional is obtained.B5, h10 - correct field name for udi h3 other text : other - device not returned; single use device.

• 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: 18346584
• MDR Text Key: 331064986
• Report Number: 1221359-2023-01763
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/24/2023
• Device Catalogue Number: 195-000
• Device Lot Number: 215643
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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