MAUDE Adverse Event Report: SENSEONICS, INCORPORATED EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number 102208-005

Device Problem Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 07/27/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.User did not provide date and time of the incident nor the glucose values to perform a data management system (dms) review or further investigation.Furthermore, it was determined that the transmitter was outside of warranty period.Patient was advised to purchase a new transmitter to renew the warranty.Patient was given coke by the paramedics after which he felt fine.No further actions were possible for this issue.

Event Description

Senseonics was made aware of a serious adverse event due to hypoglycemia.Patient became dizzy and disoriented and fainted.Patient was treated by paramedics and was not hospitalized.Patient did not provide any date and time of the event nor provided any further information.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18998171
• MDR Text Key: 338879307
• Report Number: 3009862700-2024-00365
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2024

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 Expiration Date: 02/21/2022
• Device Model Number: 102208-005
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 122634
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other