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

Model Number 102208-751

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 07/17/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.The rma was authorized for the transmitter to be returned for further evaluation.But the device was not received, thus no confirmation or investigation of the complaint was possible.There is no remedial action/corrective action/preventive action/field safety corrective action required.

Event Description

Senseonics was made aware of an incident where the patient complained that transmitter was getting hot while charging and while using.Patient mentioned that transmitter was never dropped and never have been placed in a hot surface or hot compartment and never touched water.The incident has not led to any injuries.

• 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: 18278866
• MDR Text Key: 330430010
• Report Number: 3009862700-2023-00611
• Device Sequence Number: 1
• Product Code: QCD
• 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
• 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: 01/04/2022
• Device Model Number: 102208-751
• Device Catalogue Number: FG-3400-51-001
• Device Lot Number: 121978
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2021
• 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