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

Model Number 101967-950

Device Problem Imprecision (1307)

Patient Problems Hyperglycemia (1905); Burning Sensation (2146)

Event Date 11/15/2023

Event Type  Injury  

Event Description

Senseonics was made aware of a hyperglycemia event that happened on (b)(6) 2023 at 1:28 pm.The patient reported that the sensor glucose (sg) reading at the time of incident was 341 mg/dl.The patient injected insulin based on the sg reading and went into hypoglycemia state later.The patient did not measure blood glucose (bg) value at the time of incident.

Manufacturer Narrative

The manufacturer is currently performing evaluation and the results will be provided in a supplemental report.

Manufacturer Narrative

The customer experienced a hyperglycemic event and subsequently administered insulin.However, they then encountered a hypoglycemic episode leading to a serious adverse event where ambulance was called (complaintrec-.43869 / bfarm ref : (b)(4)) the initial investigation was performed on the user synced glucose data on data management system (dms), which is a cloud platform for eversense systems.Based on the initial analysis, the customer reported sensor glucose (sg) value of 341 mg/dl was confirmed.No blood glucose (bg) value was reported or was entered into the system.The customer received multiple high glucose alerts as the sg value crossed above the set high glucose alert threshold.A review of the overall system performance suggested a deviation from the typical behavior.Due to this deviation and to determine the root cause, a return material authorization (rma) was issued for sensor return and replacement.The returned sensor was investigated and found to be performing as expected as it passed all the functional tests.This may occur in some instances where the failure mode that presents itself in the body cannot be reproduced in the lab.However, a further analysis of the in-vivo glucose data revealed noise in the glucose channel for days until the hypoglycemic event.The potential root cause of the noise could be due to transient issue with sensor electronics, for example the led behavior at the time of incident, or the in-vivo state of sensor hydrogel (chemical component of the sensor), which cannot be reproduced in the laboratory.As part of resolution, the customer was inserted with a new sensor to continue using eversense e3 continuous glucose monitoring (cgm) system.B4.Date of this report 26 april 2024 g3 date received by the manufacturer ?12 feb 2024 h3.Device evaluated by manufacturer? yes h6.Type of investigation updated to 10 h6.Investigation findings updated to 4203 h6.Investigation conclusions updated to 4307.

• Brand Name: EVERSENSE SENSOR
• 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: 18314256
• MDR Text Key: 330308829
• Report Number: 3009862700-2023-00827
• Device Sequence Number: 1
• Product Code: QHJ
• 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,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/12/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• 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