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

Model Number 102208-805

Device Problem Overheating of Device (1437)

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

Event Date 07/26/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The transmitter was requested to be returned to senseonics for investigation, however, it was never returned.Based on findings on similar incidents, the transmitter overhaeting issue was related to a defective battery.The issue was further investigated and addressed through a corrective and preventative action (capa).The user was given a new transmitter to continue using the system.

Event Description

Senseonics was made aware of an incident where the patient reported that five minutes after keeping the transmitter in the charging cradle for charging, it started to to burn with smoke.The transmitter encasement opened by itself from the incident, and a slight crack was visible on the side of the transmitter.Nobody was hurt but a strange sound was heard when the incident happened like a signal or beeping.

• 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: 18490097
• MDR Text Key: 333093964
• Report Number: 3009862700-2023-00486
• Device Sequence Number: 1
• Product Code: QCD
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/10/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/23/2019
• Device Model Number: 102208-805
• Device Catalogue Number: FG-3400-05-101
• Device Lot Number: 109210
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2018
• 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