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

Model Number 101967-950

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 06/22/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The initial investigation was performed on the user synced glucose data on data management system (dms), which is an eversense cloud platform.Based on the dms analysis, the system was not in use at the time of the event.A review of the sensor alert history revealed that the sensor was already retired as the system asserted an early sensor replacement alert on (b)(6) 2023.The sensor was replaced on (b)(6) 2023.Due to early sensor retirement, the rma was issued for return of sensor for further investigation.Investigation of the returned sensor did not reveal any malfunction as it passed all the functional tests.This may occur in some instances where the failure mode that presents itself in the body cannot be reproduced in the lab.A further review of the glucose plot revealed that on (b)(6) 2023, there were 4 consecutive suspicious calibrations which led to sensor suspend per design.This feature allows the system to re-evaluate its performance and re-start in initialization phase, while the sensor glucose is blinded to the user for 6 hours.After the system was out of the sensor suspend phase, it restarted in initialization phase and on the (b)(6) 2023, there were another 4 consecutive suspicious calibrations leading to another sensor suspend.As per design, if there are two sensor suspend alerts asserted within 14 days, then the system will retire the sensor and assert a sensor replacement alert.A review of the in-vivo glucose data revealed that the historical calibration entries were not accurate i.E, the customer was entering the sensor glucose (sg) readings for calibration.Entering anything other than true fingerstick blood glucose (bg) reading would disrupt the normal functioning of the sensor and cause significant inaccuracies.

Event Description

Senseonics was made aware of an incident where the customer experienced hypoglycemia on (b)(6) 2023 leading to unconsciousness.The system was not in use at the time of incident because of premature sensor retirement.The customer was hospitalized for 3 weeks.The customer's hcp is aware of the incident.The customer is now doing fine and awaiting re-insertion.No further information was provided by the user.Senseonics recommended customer to consult their hcp for any medical assistance.

• 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: 18117168
• MDR Text Key: 327886112
• Report Number: 3009862700-2023-00229
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• 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): Hospitalization