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

Model Number 101967-750

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

Patient Problems Discomfort (2330); Fibrosis (3167)

Event Date 04/06/2022

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.Inability to remove sensor is a known and anticipated potential adverse effect, which does not require additional investigation by manufacturer.Tissue growth around the sensor is an expected phenomenon and the sensor is designed to be biocompatible.The regular doctor could not grasp the sensor because of fused tissue and hence asked patient to go to the hospital to have a surgeon remove it.No emergency services were called nor patient required any hospitalization.The sensor was successfully removed by the surgeon and incision site was sutured.Per case information, patient is doing well and currently using eversense xl cgm system with up to date glucose information.There is no remedial action/corrective action/preventive action/field safety corrective action required.

Event Description

Senseonics was made aware of an incident where patient reported a failed sensor removal attempt on (b)(6) 2022 because the doctor couldn't grasp the sensor as it was fused to the tissue.The doctor asked to go to the hospital to have a surgeon removed it.Emergency services weren't called, patient wasn't taken to an emergency room and wasn't hospitalized.Sensor was successfully removed by a surgeon and the insertion site was sutured.No medication was prescribed.The patient is doing well.

• 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: 18268031
• MDR Text Key: 329739443
• Report Number: 3009862700-2023-00760
• Device Sequence Number: 1
• Product Code: QCD
• 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: 12/05/2023

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: 03/08/2022
• Device Model Number: 101967-750
• Device Catalogue Number: FG-4400-50-302
• Device Lot Number: WP08438
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• 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