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

Model Number 102208-750

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 09/29/2022

Event Type  malfunction  

Event Description

Senseonics was made aware of a incident where patient felt transmitter very warm to touch after charging.It was reported that the transmitter was showing signs of physical damage.A return material authorization (rma) was issued to return the transmitter for further investigation.No patient harm was reported.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.The transmitter was requested to be returned for further evaluation.However, the device was never received.Thus, no confirmation or investigation of the complaint was possible.As part of resolution, the user was offered a transmitter replacement.There is no remedial action/corrective action/preventive action/field safety corrective action required.

• 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: 18278875
• MDR Text Key: 330123686
• Report Number: 3009862700-2023-00807
• 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
• Type of Report: Initial
• Report Date: 12/06/2023

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: 02/16/2022
• Device Model Number: 102208-750
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 122419
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2021
• 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