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

Model Number	102208-600
Medical Device Problem Codes	Fire (1245); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, senseonics was made aware of an event where the user's transmitter was burned after plugging in the cradle and putting the transmitter on the charger.The charging cradle began to smoke and spark which started a fire, causing the transmitter and charging components to be burned.
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Additional Manufacturer Narrative
On (b)(6) 2024, at 7:13 pm, the user reported that when they plugged the transmitter into the charging cradle, it started smoking and sparking, eventually catching fire and burning completely.This incident occurred in an airport, thus the fire department intervened, retrieving the damaged components.The user reported that the issue seemed to be with the cradle, not the usb cable or power supply.The user also mentioned they did not observe any damage with the charging accessories, no exposed wires or cracks.Since the damaged parts burned completely and were taken by the fire department, the lot number and manufacturing date on the charging cradle could not be gathered.An rma was issued for the replacement of the transmitter, and an additional case (b)(4)) was created to document the damaged charging components.There were no other prior reported complaints for the user's transmitter and charging components.Review of the alert history in the data management system (dms) showed no high transmitter temperature alerts for the entire duration of transmitter usage.Potential root causes of the incident could have been an excessive current draw due to a transmitter battery short, charger failure due to environmental conditions, or damaged power adapter.No further investigation is possible because the parts were taken by the fire department.B4.Date of this report updated to 11 november 2024.G3 date received by the manufacturer? 11 november 2024.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 4203.H6.Investigation conclusions updated to 4307.

• Brand Name: EVERSENSE TRANSMITTER
• Common Device Name: 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: 20164410
• Report Number: 3009862700-2024-00901
• Device Sequence Number: 7291344
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 00817491022912
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/03/2024
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 138467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male