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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progess.A supplemental report will be provided after completion.

Event Description

The consumer reported getting reagent solution from the binaxnow covid-19 antigen self test in her eyes.The consumer was told to consult her doctor if there is any discomfort.A safety data sheet was sent to the consumer.Although requested, additional information, including patient treatment and outcome was not provided.

Manufacturer Narrative

Additional information: consumer followed up stating that no medical treatment was required; rinsed eyes with water.

Manufacturer Narrative

Corrected data: g4: eua number corrected.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 antigen self-test 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 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: elissa zavorotny ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12813353
• MDR Text Key: 280804696
• Report Number: 1221359-2021-03472
• 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: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• 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: 04/20/2022
• 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: Female