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

Model Number 101967-950

Device Problems Installation-Related Problem (2965); No Apparent Adverse Event (3189)

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

Event Date 10/12/2023

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 and if the sensor is inserted, this would result in inconsistent or weaker connection with the transmitter, affecting the normal functioning.In this incident, the customer complained of receiving frequent "no sensor detected" alerts.The customer mentioned having the issue since the day of insertion.When the customer tries to establish the connection the placing the transmitter over the insertion area by following placement best practices, the connection loses upon making hand movements.The issue was escalated and a review of transmitter diagnostic log revealed a weaker signal strength between the sensor and the transmitter.It was determined that the sensor was inserted deeper than usual.The customer was recommended to consult with hcp regarding the removal of sensor.The most likely root cause of the issue is the procedural error from the inserting doctor.This incident does not require any further investigation.

Event Description

Senseonics was made aware of an incident where the sensor was removed from the patient's arm because it was inserted too deep resulting in the weaker connection with the transmitter.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 18117230
• MDR Text Key: 327879826
• Report Number: 3009862700-2023-00305
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: PL
• 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 Expiration Date: 11/24/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09146
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2022
• 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