MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR 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 11/02/2023

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where the patient was recommended to have their sensor removed because it was determined to have inserted too deep resulting in the frequent sensor disconnections.The sensor was inserted on (b)(6) 2013 and since then the patient received "no sensor detected" alerts very often.

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 sensor was inserted on 01 november 2013 and since then the sensor connection with the transmitter was very weak resulting in frequent sensor disconnections ('no sensor detected' alerts).This was confirmed via a review of data management system (dms) which is an eversense cloud platform.Initially the customer was advised to wait until the tegaderm film or the bandage (after the insertion procedure) is completely removed as they can weaken the signal strength.However, even after the removal of the bandage, the issue persisted and the customer could not get a good signal.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 customer visited hcp who did an ultrasound and confirmed that the sensor was indeed inserted deeper than usual.The most likely root cause of the issue is the procedural error from the inserting doctor.This incident does not require any further investigation.

• 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: 18361378
• MDR Text Key: 330930869
• Report Number: 3009862700-2023-00833
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09143
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2023
• 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