MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG CARD; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195-000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burning Sensation (2146); Skin Inflammation/ Irritation (4545)

Event Date 12/30/2020

Event Type  Injury  

Manufacturer Narrative

Customer was provided instruction/training for the correct procedure as well as the safety data sheets for the kit.No additional information, evaluation or clarification of data is applicable.The reported event is anticipated in nature and severity for binaxnow covid-19 ag card and captured within the product's risk management file.No additional action is necessary.

Event Description

The patient reported that the swab used to collect nasal samples on (b)(6) 2020 from both nostrils contained binaxnow covid-19 ag extraction reagent solution.The customer reported experiencing subsequent irritation in both nasal cavities up to the eye and irritation in the throat.The customer reported an exam by a physician who recommended a standard nasal saline spray to be swabbed in the nasal cavity.On (b)(6) 2020, the customer reported an irritation in the right eye and light inflammation in the left nasal cavity.On (b)(6) 2021, the patient reported that she was fine now, and the inflammation in her nostril has reduced.The customer reported that she does not have any further appointment with the doctor at the moment.The patient confirmed no death or serious injury, and she did not experience any delays/impact to treatment.The extraction reagent packaged in this kit contains saline, detergents and preservatives that will inactivate cells and virus particles.Samples eluted in this solution are not suitable for culture.Due to the ingredients of the reagent and the sensitive nature of the nose, there is moderate risk of serious injury to the nose.Therefore, the incident shall be considered reportable.

• Brand Name: BINAXNOW 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 (Section G): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: alonna pitreau ; 10 southgate road; scarborough, ME 04074 ; 2077305750
• MDR Report Key: 11229995
• MDR Text Key: 230032735
• Report Number: 1221359-2021-00214
• 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: Other
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 195-000
• Date Manufacturer Received: 12/30/2020
• 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