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

Model Number 102208-005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Hyperglycemia (1905); Nausea (1970); Dizziness (2194)

Event Date 10/21/2019

Event Type  Injury  

Event Description

On october 21, 2019, senseonics became aware of an event where a user was hospitalized due to a hyperglycemia event.The user felt nauseous, was not able to think straight, felt dizzy, fell down and broke her sternum.The user's son called for the ambulance and she was admitted to the hospital.The user also reported that the incident did not happen because of eversense system's malfunction but due to lack of training.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.As reported, the user did not calibrate correctly which ultimately caused the hospitalization incident.The user reported that it was not due to any malfunction of the device but due to lack of training that she had on how to use the device.No remedial action/corrective action/preventive action/field safety corrective action is required.Since the exact date and time of the event remained unknown, no further investigation could be possible from the manufacturer.Based on the information available and what user reported, there was no malfunction associated with the device and the device performed as intended.

• 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: 18415817
• MDR Text Key: 331577285
• Report Number: 3009862700-2023-00414
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/21/2020
• Device Model Number: 102208-005
• Device Catalogue Number: FG-3400-XX-101
• Device Lot Number: 112792
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2020
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• 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
• Patient Outcome(s): Hospitalization