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

Model Number 101967-750

Device Problem Imprecision (1307)

Patient Problems Headache (1880); Hypoglycemia (1912)

Event Date 10/02/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Transmitter was the initial suspected device.However, preliminary investigation analysis revealed a deviation (from the normal behavior) in the sensor performance.The preliminary investigation was performed on the user's in vivo sensor data synced by the user on the data management system (dms), which is the data cloud platform for eversense systems.To further analyze the performance deviation and to determine the root cause of the malfunction, a return material authorization (rma) was authorized to bring back the sensor.But since the device was never returned.Hence no root cause analysis was possible.

Event Description

On october 12, 2022, senseonics was made aware of a hypoglycemia incident where patient complained of inaccurate sensor readings.Patient didn't provide a blood glucose reading but mentioned that the sensor glucose reading was 91 mg/dl.Patient did not receive a low glucose alert and was symptomatic.Patient had symptoms such as headache and blurry vision.Patient self treated with water and sugar.

• Brand Name: EVERSENSE SENSOR
• 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: 19009470
• MDR Text Key: 338980572
• Report Number: 3009862700-2024-00372
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491023360
• UDI-Public: 817491023360
• 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: 03/31/2024

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: 07/14/2022
• Device Model Number: 101967-750
• Device Catalogue Number: FG-4400-50-302
• Device Lot Number: WP08492
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other