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

Model Number 101967-950

Device Problems Communication or Transmission Problem (2896); No Apparent Adverse Event (3189)

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

Event Date 03/21/2024

Event Type  Injury  

Manufacturer Narrative

A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.A subcutaneous pocket of 3mm - 5mm deep will be created under the skin and the sensor will be inserted in this pocket.If the insertion pocket is too deep, this would result in inconsistent or weaker connection with the transmitter, affecting the normal functioning.Since the customer mentioned that the sensor was unable to be palpated, the possible reason could be that sensor was inserted deeper than usual.Hence, the customer was advised to go back to hcp for replacement of sensor.When the customer went to hcp, they were able to link sensor and transmitter, but it soon got disconnected.The hcp said they would schedule an appointment for sensor replacement.However, the date has not been scheduled yet.Since this is a procedure related adverse event, this does not require any further investigation.

Event Description

On march 25, 2024, senseonics was made aware of an incident where the sensor was unable to be palpated and more pressure needed to be applied to get establish signal between sensor and transmitter.This often resulted in sensor disconnections and the customer was able to use the system normally.The customer was advised to go back to hcp for an additional procedure to get the current sensor removed and to get inserted with a new one.The sensor was inserted on (b)(6) 2023.

• 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: 19149727
• MDR Text Key: 340677665
• Report Number: 3009862700-2024-00644
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/24/2024
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09243
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2023
• 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