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

Model Number UNKNOWN

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

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

Event Date 10/05/2022

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where newly inserted sensor removed because of the signal interference with the older three sensors which were all still inside the same arm.The old sensors could not be removed initially because of their close proximity to the new one.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 all sensors including most recent (new) one and to get inserted with a fresh sensor, preferably in other arm.

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 sensors.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 all the older sensors along with the one which couldn't be used.User was advised to get inserted with a fresh one, preferably in other arm.As per the information received by senseonics, all the previous sensors were removed successfully from the left arm on (b)(6) 2022.A new sensor was inserted in the right arm to continue using eversense system.User is doing well and the bruises from the removal procedure is healing.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18117203
• MDR Text Key: 327873791
• Report Number: 3009862700-2023-00236
• Device Sequence Number: 1
• Product Code: QHJ
• 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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2022
• 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