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

Model Number 102208-005

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); Insufficient Information (4580)

Event Date 04/25/2019

Event Type  Injury  

Event Description

Senseonics was made aware of an instance where the patient experienced a hypoglycemia event which probably happened on (b)(6) 2019.The exact date and time of the event is not known.No other information such as blood and sensor glucose values were provided.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The exact date and time of the event is unknown and the nurse practitioner was unsure of the exact date.The investigation was performed on the user synced glucose data to data management system (dms), which is a cloud platform for eversense system.Based on the investigation conducted on the available glucose information, the device asserted multiple low glucose alerts on (b)(6) 2019.Investigation did not find any evidence of the device malfunction.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 18423342
• MDR Text Key: 331770056
• Report Number: 3009862700-2023-00421
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 01/01/2024

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: 01/29/2019
• Device Model Number: 102208-005
• Device Catalogue Number: FG-3400-XX-XX1
• Device Lot Number: 106134
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 01/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other