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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

The insertion of new sensor was off label since it was inserted in a close proximity to the older sensor.This would create 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 normal usage of the system will not be 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 hcp scheduled removal appointment for on (b)(6) 2024.At the time of reporting this incident, removal confirmation is not available.

Event Description

On march 8, 2024, senseonics was made aware of an incident where the old sensor could not be removed during removal procedure on (b)(6) 2024 and a new sensor was inserted next to the old one during same appointment.As this is off -label, the patient was advised to visit hcp to have both sensor removed 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: 19056169
• MDR Text Key: 339547830
• Report Number: 3009862700-2024-00603
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023308
• UDI-Public: 817491023308
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP08959ME
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2022
• 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