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

Model Number 101368-67A

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/06/2019

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.The risks identified for the eversense¿ cgm system are common to all cgm systems even though a minor surgical procedure is required for insertion and removal of the sensor.These include local infection, pain or discomfort, inflammation, bleeding at the insertion or removal site, bruising, itching, scarring or skin discoloration, hematoma, erythema, adhesive tape irritation and sensor fracture.There is no remedial action/corrective action/preventive action/field safety corrective action required in this case as the device is not defective.The potential develop pain at the insertion site is a known and anticipated adverse effect of the system.The patient visited the healthcare facility and they decided to remove the sensor on his request.

Event Description

Senseonics was recently made aware of an incident where the patient reported pain and swelling at the insertion site since the insertion of the eversense sensor.The patient went to the hospital to obtain painkillers to reduce the pain and swelling, however, the pain and swelling did not subside.As a result, the sensor was removed from the patient.

• 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 20876-7005
• MDR Report Key: 18271385
• MDR Text Key: 329775900
• Report Number: 3009862700-2023-00340
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• 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: 05/25/2019
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4400-XX-302
• Device Lot Number: WP04393
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2018
• 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