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

Catalog Number 195-160

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 consumer reported for her husband who broke out in severe hives after using the binaxnow covid-19 antigen self test.Although requested additional information, including patient treatment and outcome was not provided.

Manufacturer Narrative

Additional information b5: consumer provided information regarding having sought medical attention.

Event Description

Customer reported seeking medical attention.No further information was provided regarding treatment, outcome or health status.

Manufacturer Narrative

Investigation report: the information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend/unexpected performance at the lot and product family level.Based on the above summary the investigation is deemed complete.The product will continue to be monitored and tracked.

• Brand Name: BINAXNOW COVID-19 ANTIGEN SELF TEST
• 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: 13042565
• MDR Text Key: 282486243
• Report Number: 1221359-2021-03745
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2022
• 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 Sex: Male