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

Model Number 102208-904

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

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.The sensor is inserted by making a small incision and placing it under skin and potential for developing skin irritation/inflammation/infection at the insertion site is a known anticipated adverse event.Sensor had already stopped working as it had reached the 180th day since insertion.Hence, there was no product issue associated with this incident.Pain occurred because of inability to remove sensor during initial attempt.The most likely root cause for this is due to removal procedure.

Event Description

On (b)(6) 2021, senseonics was made aware of an instance where the user experienced pain at the insertion site, which caused swelling.The user described that the problem had been due to inability to remove sensor from the arm after it completed its intended use period of 180 days.The user was taken to the emergency room.No information is available as to what treatment was received.

• 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: 18435817
• MDR Text Key: 331802525
• Report Number: 3009862700-2023-00559
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491023384
• UDI-Public: 817491023384
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 01/03/2024

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: 01/02/2024
• Device Model Number: 102208-904
• Device Catalogue Number: FG-3500-04-001
• Device Lot Number: 134895
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2023
• 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