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

Model Number 101967-950

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

Patient Problem Implant Pain (4561)

Event Date 05/08/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of 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/swelling/pain/ inflammation/infection around the insertion site is a known anticipated adverse event.In addition, the user guide mentions that the adhesive patches may cause reaction or skin irritation and any medical issues or symptoms caused should be reported to the health care provider.In this case, the er physician who treated the patient for intense pain suggested sensor removal because they thought the issue might be due to sensor.However, the patient's hcp did an ultrasound and found tendon inflammation and bursitis.The patient's hcp said the issue was not due to sensor and a removal is not needed.The patient is currently doing fine after taking paracetamol treatment.The er physician also suggested patient to take painkillers or inflammatory meds in required.This incident does not require any further investigation and the patient should see doctor in case of any medical guidance.

Event Description

Senseonics was made aware of an incident where patient was admitted to hospital due to intense pain at the insertion site on (b)(6) 2023.The pain began one month after the sensor insertion on (b)(6) 2023.Patient also had symptoms such as muscle stiffness and burning sensation.The emergency room (er) physician suggested patient to urgently remove sensor and was treated with paracetamol via iv.The patient consulted physician who did ultrasound and found tendon inflammation and bursitis.The physician said the event was not related to sensor and it does not have to be removed.

• 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: 18117089
• MDR Text Key: 327882476
• Report Number: 3009862700-2023-00228
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 11/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization