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

Catalog Number 195-160

Device Problem Leak/Splash (1354)

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

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.

Event Description

The user reported when adding drops from the dropper bottle, some of the liquid squirted to the user's wife's eye.

Manufacturer Narrative

The customer reported stinging in their eyes after the reagent was squirted in their eyes.Technical services advised the customer to flush their eye with copious amounts of water and to seek medical attention if irritation persists.Technical services could not provide the sds.According to the package insert in195150c v3.0: precautions 20.The reagent solution contains a harmful chemical (see table below).If the solution contacts the skin or eye, flush with copious amounts of water.If irritation persists, seek medical advice: https://www.Poison.Org/contact-us or 1-800-222-1222.Based on the above summary the investigation is deemed complete.The product will continue to be monitored and tracked.

Manufacturer Narrative

Corrected data - d1 and g4 addtional information provided - g1 and d3.

• Brand Name: BINAXNOW COVID-19 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: 12587203
• MDR Text Key: 275139140
• Report Number: 1221359-2021-03083
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081722020410148988
• 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: 12/02/2022

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: Lay User/Patient
• Device Catalogue Number: 195-160
• Device Lot Number: 148988
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 04/13/2022; 11/28/2022
• Supplement Dates FDA Received: 05/03/2022; 12/02/2022
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White