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

Model Number 102208-005

Device Problems Imprecision (1307); Calibration Problem (2890)

Patient Problem Hyperglycemia (1905)

Event Date 12/03/2021

Event Type  Injury  

Manufacturer Narrative

The investigation was performed on the user synced glucose data in data management system (dms), which is a cloud platform for eversense systems.The investigation was performed on the user synced glucose data in data management system (dms), which is a cloud platform for eversense systems.Based on the investigation analysis on user's data in data management system (dms), the complaint was not confirmed, as the reported mismatch was not found in the in vivo data, and the key performance parameters look good.There was no malfunction with the system.No further investigation was found necessary.

Event Description

Senseonics was made aware of a hyperglycemia event due to alleged sensor inaccuracies on (b)(6) 2021 at around 11:05 pm.The blood glucose (bg) value was 239 mg/dl where as sensor glucose (sg) value was 129 mg/dl.Since the high alert threshold was set at 200 mg/dl, user did not receive high glucose alerts.Since the user was not symptomatic, they did not require any medical treatment and was able to self treat with insulin.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUOCSE 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: 18754866
• MDR Text Key: 335931915
• Report Number: 3009862700-2024-00308
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): N
• 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: 02/21/2024

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: 02/02/2022
• Device Model Number: 102208-005
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 122419
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other