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 Use of Device Problem (1670)

Patient Problems Red Eye(s) (2038); Eye Burn (2523)

Event Date 12/14/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The consumer reported that the extraction reagent from the binaxnow covid-19 antigen self test came in contact with the eyes on (b)(6) 2021.The consumer spoke with technical services (ts) and stated that he rinsed his eyes for five minutes, the consumer stated he was experiencing eye redness and stinging.Ts connected the patient with a local poison and drug services line for further medical advice on how to proceed.Due to privacy reasons ts had to release the call once the consumer was connected to a specialist at the local poison and drug services center.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Technical services followed up with the customer and they confirmed they received the sds.They stated their eyes are fine and they are not carrying the reagent in their pocket to avoid this mistake from occurring again.According to the package insert in195150c v.3.0: precautions 20.The reagent solution contains a harmful chemical.If the solution contacts the skin or eye, flush with copious amounts of water.If irritation persists, seek medical advice.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 ; 6613888803
• MDR Report Key: 13211802
• MDR Text Key: 283576582
• Report Number: 1221359-2022-00018
• 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: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2022
• 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 Sex: Male