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

Model Number 102208-705

Device Problem Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 03/17/2020

Event Type  Injury  

Event Description

Senseonics was made aware of an instance where the patient experienced few hypoglycemia episodes.Patient called in to mention how often it happened rather than providing specific instance or examples.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Since the user/distributor stopped responding to follow-up requests, it cannot be confirmed if there was any malfunction of the system.No further information or specific date was provided other than complaining about hypoglycemia.

• Brand Name: EVERSENSE SMART 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: 18283299
• MDR Text Key: 329947536
• Report Number: 3009862700-2023-00445
• 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: 12/07/2023

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: 09/27/2020
• Device Model Number: 102208-705
• Device Catalogue Number: FG-3400-05-001
• Device Lot Number: 116082
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2019
• 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): Other