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 Missing Information (4053)

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

Event Type  Injury  

Event Description

The consumer reported that while attempting to open the binaxnow covid-19 antigen self test reagent solution, he experienced a "few drops" in his eyes when the top "snapped off".The ifu does provided instructions for opening the reagent bottle: it says: remove dropper bottle cap.The instructions to remove it are there- just not specifically how.The consumer reported the test kit did not contain instructions for how to open the reagent bottle.

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.The reagent sds (safety data sheet) was provided to the consumer.

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: 12805740
• MDR Text Key: 281832493
• Report Number: 1221359-2021-03394
• 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
• 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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Device Lot Number: 156699A
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 04/21/2022
• 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
• Patient Sex: Male