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

Model Number 101967-950

Device Problem Output Problem (3005)

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

Event Date 02/14/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Investigation of the returned sensor did not reveal any malfunction as it passed all functional tests and visual inspection.Transmitter log file analysis confirmed the customer complaint but could not be reproduced in the lab during testing.The potential root cause for missing glucose data can be due to incompatibility between sensor calibrated parameters and the algorithm of the system.As part of resolution, the customer was given a new transmitter and a sensor.After this, the customer confirmed that glucose values are being displayed to her.No further investigation was found necessary for this complaint.

Event Description

Senseonics was made aware of an incident where the eversense app did not display any glucose values.Customer started initialization phase from the beginning several times, but no glucose value was displayed.A transmitter reset did not resolve the issue and a transnmitter replacement was also unsuccessful.The issue was further escalated to engineering support (l3) who decided to issue a sensor replacement.This issue is being reported due to early sensor removal.

• 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: 19009302
• MDR Text Key: 338982465
• Report Number: 3009862700-2024-00422
• 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: 03/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1