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

Model Number 101967-750

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

Patient Problem Discomfort (2330)

Event Date 08/04/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The insertion of new sensor was off label since it was inserted in a close proximity to the older sensor.This in turn created a signal interference issue for the user with the new sensor.Overall, the most likely root cause of this incident is due to the procedural error from the inserting physician as the new one should have been inserted in the other arm.The doctor decided to remove both sensors and inserted another new sensor in the other arm.

Event Description

Senseonics was made aware of an incident where newly inserted sensor had to removed because of the signal interference with the older sensor which was still inside the arm.The first (old) sensor could not be removed and a second pocket was placed in the same incision with the new sensor.Since the usage of the system wasn't possible due to sensors being in the same pocket, the sensors were removed.Another new sensor was inserted in the other 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: 19008433
• MDR Text Key: 338978781
• Report Number: 3009862700-2024-00237
• 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: 03/29/2024

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 Model Number: 101967-750
• Device Catalogue Number: FG-4400-10-302
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 03/29/2024
• 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): Other