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

Model Number 101368-67A

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

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

Event Date 11/21/2018

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.A review of the device's manufacturing documentation revealed that the sensor lot met sterilization requirements before release.The sensor is inserted by making a small incision and placing it under skin and potential for pain and swelling at the insertion site is a known anticipated adverse event.Patient visited hcp who decided to remove sensor from the arm to alleviate the symptoms.After sensor removal, the patient is no longer having pain and swelling anymore.

Event Description

Senseonics was recently made aware of an incident where one of the patients who was inserted with an eversense sensor developed pain and swelling at the insertion site since over one year.Patient sought physiotherapy which did not help.The patient was recommended to consult a neurologist.The customer had some tests with an orthopedic and neurologist and is waiting for some documents and results.Sensor was removed by the doctor.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 18423336
• MDR Text Key: 331767040
• Report Number: 3009862700-2023-00418
• 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: 01/01/2024

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: 12/20/2018
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4400-XX-302
• Device Lot Number: WP04171
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 01/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2018
• 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