MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR

Model Number 101967-950

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/09/2023

Event Type  Injury  

Manufacturer Narrative

This mdr is result of a retrospective review of complaints.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.A subcutaneous pocket of 3mm - 5mm deep will be created under the skin and the sensor will be inserted in this pocket.If the insertion pocket is too deep and if the sensor is inserted, this would result in inconsistent or weaker connection with the transmitter, affecting the normal functioning.The sensor was inserted on (b)(6) 2023 and the user persistently received multiple "no sensor detected" alerts.The patient was advised to see the hcp for assistance with locating the sensor, or removal and replacement of the sensor based on the discretion of the hcp.The hcp recommended removal of the sensor as it was believed to have been inserted too deep.The sensor was removed and a new sensor was inserted in the right upper arm.The patient is doing fine.This incident does not require any further investigation.

Event Description

Senseonics was made aware of an incident where the user was newly inserted and persistently received multiple "no sensor detected" alerts.The patient was advised to see the hcp for assistance with locating the sensor, or removal and replacement of the sensor based on the discretion of the hcp.

• Brand Name: EVERSENSE SENSOR
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR
• 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: 18603632
• MDR Text Key: 334022575
• Report Number: 3009862700-2024-00030
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023308
• UDI-Public: 817491023308
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/24/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09143
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2022
• 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