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 Blurred Vision (2137); Burning Sensation (2146)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The user reports while doing the binaxnow covid-19 antigen self test he dropped some solution in his eye.The was advised to rinse with clear water and if necessary to seek medical attention.Additional information was requested but not provided.

Manufacturer Narrative

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

Event Description

The user reports while doing the binaxnow covid-19 antigen self test he dropped some solution in his eye.The was advised to rinse with clear water and if necessary to seek medical attention.Additional information was requested but not provided.

Manufacturer Narrative

The supplemental report is being submitted to provide the investigation conclusion.Technical services was able to provide the customer with the safety data sheet for reagent.Customer confirmed that no medical attention was required and there were no additional issues.A product deficiency was not reported or identified.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: 13339346
• MDR Text Key: 285174683
• Report Number: 1221359-2022-00531
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Device Lot Number: 101445403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2022
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 104 KG