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

Model Number 101967-710

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

Patient Problems Myalgia (2238); Discomfort (2330); Swelling/ Edema (4577)

Event Date 02/22/2021

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/pain/ inflammation/infection at the insertion site is a known anticipated adverse event.It was last reported that the sensor will be removed on (b)(6).But no further information was received despite making several attempts.

Event Description

On (b)(6) 2021, senseonics was made aware of an incident where patient experienced pain at the insertion site after using the sensor for almost 6 months.Removal date was scheduled in the beginning of march.The patient felt pain for the last three days when insertion site is touched or when moving arm.It was a bit swollen but no redness.Patient said she will go see a doctor and if necessary removal date will be moved forward.

• 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: 18435819
• MDR Text Key: 331859344
• Report Number: 3009862700-2023-00564
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: AU
• 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: 10/25/2020
• Device Model Number: 101967-710
• Device Catalogue Number: FG-4400-10-302
• Device Lot Number: WP07653
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2019
• 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