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

Model Number 101967-950

Device Problem Imprecision (1307)

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

On february 1, 2024, senseonics was made aware of an incident where the patient complained of inaccurate sensor readings.Patient removed transmitter from his arm for few days due to travel and when he decided to wear the transmitter on and do the pairing again, he could not calibrate.During the calibrations, patient received alerts of low glucose but in actual, the blood glucose (bg) values were not low.Patient tried to do the calibrations twice, but he couldn't complete them.A review of the glucose data on the data management system (dms) suggested a deviation in the system performance and hence a sensor replacement was approved.There were no adverse events associated with this incident and no medical attention was required.The patient will have the sensor removed.

Manufacturer Narrative

The manufacturer is currently performing investigation and the results will be provided in the supplemental report.

Manufacturer Narrative

The initial investigation was performed on the user synced glucose data in data management system (dms), which is a cloud platform for eversense systems.Based on the initial investigation analysis, there was a deviation in the system performance.The sensor raw sensor data showed gaps and deterioration of the signal and reference channel.This is characteristic of a shorted/ disconnected led which could result in a drop off in the signal/reference channels.To further investigate the sensor and to determine the actual root cause, a return material authorization (rma) was issued for the sensor.The returned sensor was investigated which revealed an led crash (permanent loss of sig and ref signals), which confirms the root cause.As part of resolution, the customer was given a sensor replacement.No further investigation was found necessary for this complaint.B4.Date of this report updated to (b)(6) 2024.G3.Date received by manufacturer updated to (b)(6) 2024.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 4203.H6.Investigation conclusions updated to 4307.

• 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: 18794331
• MDR Text Key: 337018564
• Report Number: 3009862700-2024-00049
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/03/2024
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2023
• 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