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

Model Number 102208-905

Device Problems Failure to Charge (1085); Electrical /Electronic Property Problem (1198); Excessive Heating (4030)

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

Event Date 01/19/2024

Event Type  malfunction  

Event Description

On january 20th, 2024, senseonics was made aware of an incident where the patient complained that transmitter becomes very hot during charging.Additionally, the patient complained that the transmitter is not charging despite trying with two different sets of charging components.To further investigate the complaint, the return material authorization (rma) was issued for the transmitter replacement.This incident did not result in any adverse events.

Manufacturer Narrative

This mdr is a result of retrospective review of complaints.The manufacturer is currently performing investigation and the results will be provided in the supplemental report.

Manufacturer Narrative

The patient complained that transmitter becomes very hot during charging.The transmitter was requested to return back for further investigation.Investigation of the returned transmitter found that battery capacity was acceptable, but the circuit board was found to have defective diode (d3) and charger chip (u3) which causes the transmitter to dissipate more heat than expected.No further investigation was found necessary for this complaint.As part of resolution, the patient was given a new transmitter.B4.Date of this report updated to 18 april 2024.G3.Date received by manufacturer updated to 17 april 2024.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6 investigation findings updated to 120.H6.Investigation conclusions updated to 4307.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 18764767
• MDR Text Key: 336802913
• Report Number: 3009862700-2024-00039
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2023
• Device Model Number: 102208-905
• Device Catalogue Number: FG-3500-05-001
• Device Lot Number: 134194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1