MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number 102208-707

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Glucose in the interstitial fluid relative to blood is a physiologic property/limitation for interstitial sensors.The investigation showed that the sensor was tracking to the 15 minutes lag value, and the system is functioning normally, as per the labeling.To get earlier alerts the user could have set the alert threshold higher (set at 70mg/dl), especially if the user is highly sensitive to hypoglycemia.In addition, enabling predictive and rate-of-change alerts would also provide the user with more warnings and information.The user elected not to enable these alerts which contributed to their unawareness of the upcoming hypo condition.

Event Description

On september 26, 2019, senseonics was made aware of an incident where the patient experienced an hypoglycemia event.The patient reported to have not received alert during the time of incident and went unconscious.Patient did not need any medical assistance as he was assisted by a family member who gave him a coke.The patient recuperated after that.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18415822
• MDR Text Key: 331579368
• Report Number: 3009862700-2023-00409
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: BE
• 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: 12/28/2023

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: 03/26/2020
• Device Model Number: 102208-707
• Device Catalogue Number: FG-3400-07-001
• Device Lot Number: 112864
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2020
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2019
• 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): Hospitalization