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

Model Number 101967-750

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2022

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.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 pocket/other arm.Since the usage of the system wasn't possible due to sensors being close to each other, user was advised to consult with the hcp to discuss the possibility of removing both the sensors.User was advised to get inserted with a fresh sensor, preferably in other arm.As per the information received by senseonics at the time of submitting this report, the recently inserted sensor, which could not be linked due to signal interference, was removed by the doctor.However, the old sensor will be removed during the time of inserting a fresh sensor, which will be on a later date.The date was not provided by the doctor.

Event Description

Senseonics was made aware of an incident where newly inserted sensor removed because of the signal interference with the older sensor which was still inside the same arm.Since the usage of the system wasn't possible due to sensors being close to each other resulting , user was advised to consult with the hcp to discuss the possibility of removing both the sensors (old and the recently inserted one) and to get inserted with a fresh sensor, preferably in other arm.

• 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: 18117210
• MDR Text Key: 327865671
• Report Number: 3009862700-2023-00242
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023360
• UDI-Public: 817491023360
• 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: 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: 101967-750
• Device Catalogue Number: FG-4400-50-302
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2023
• 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): Other