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

Model Number 101368-67A

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

Patient Problems Implant Pain (4561); Swelling/ Edema (4577)

Event Date 07/18/2019

Event Type  Injury  

Event Description

Senseonics was made aware of incident where the user experienced pain at the insertion site.The user reported swelling, pain and redness and had difficulty moving his arm upwards.The user contacted his doctor to have the sensor removed due to the pain.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The sensor was removed by hcp from the user due to pain.The removal date was not provided.

• 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: 18490039
• MDR Text Key: 332600871
• Report Number: 3009862700-2023-00394
• Device Sequence Number: 1
• Product Code: QCD
• 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: 01/10/2024

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: 10/18/2019
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4400-XX-302
• Device Lot Number: WP04922
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2018
• 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
• Patient Sex: Male