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 Insufficient Information (3190)

Patient Problem Nasal Obstruction (2466)

Event Type  Injury  

Manufacturer Narrative

This investigation is still in progress.Once the investigation is complete a supplemental report will be provided.

Event Description

The customer reported having side effects after using the binaxnow covid-19 ag card.Per the customer, a teacher reported that she has been testing for four (4) weeks, two to three (2-3) times a week.Per the teacher, after testing she has side effects of: runny nose and days later nasal congestion and sore throat.Although requested, additional information, including patient treatment and outcome was not provided.

Manufacturer Narrative

Investigation report: 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.Based on the above summary the investigation is deemed complete.The product will continue to be monitored and tracked.

• 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 Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 13092866
• MDR Text Key: 282811980
• Report Number: 1221359-2021-03870
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 195-000
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 04/20/2022
• Supplement Dates FDA Received: 05/03/2022
• 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