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

Model Number 101967-710

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/16/2020

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where patient experienced skin irritation due to adhesive patches.It does not get red but it gets very hot.Patient visited doctor who though this might be the allergic reaction prescribed antibiotics.But even after the medication, patient developed allergic reaction again when she put on the patch.The doctor then recommended alternate continuous glucose monitoring (cgm) system.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Skin irritation due to adhesive patches is a known and anticipated potential adverse effect, which does not require additional investigation.There was no clear information if the skin irritation and allergic reactions were due to adhesive patches or sensor.Patient's physician suspected sensor to be the reason for skin irritation/allergic reaction.However, this was the 3rd sensor on the patient and the first two did not cause any skin reactions.More over, a review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.Senseonics thought this might be due to adhesive patches.Doctor recommended alternate continuous glucose monitoring (cgm) system and as a result patient decided to get the sensor removed from the arm.

• 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: 18984359
• MDR Text Key: 338659050
• Report Number: 3009862700-2024-00192
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021090
• UDI-Public: 817491021090
• 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: 03/26/2024

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: 01/09/2021
• Device Model Number: 101967-710
• Device Catalogue Number: FG-4400-10-302
• Device Lot Number: WP07769
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2020
• 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