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 01/25/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Preliminary investigation was performed on the user synced data on data management system (dms) which is a cloud platform for the glucose data.The preliminary analysis suggested that the system performance deviated from the normal behavior during the time of incident.When the system detected the performance deviation, the failsafe mechanism triggered the sensor replacement alert.To further investigate the complaint and to determine the root cause, a return material authorization (rma) was issued for the return of sensor.The investigation of the returned sensor revealed a loss of chemical performance which further indicates the oxidation of hydrogel as the root cause of the issue.As part of resolution, the a sensor replacement was offered to the patient.No further investigation was found necessary for this complaint.

Event Description

Senseonics was made aware of a hypoglycemia incident where patient complained of inaccurate sensor readings.Patient reported that blood glucose (bg) was 43 mg/dl where as sensor glucose (sg) reading was over 400 mg/dl.The patient received out of range high glucose alert even though the bg measurement suggested that the glucose was low.Patient injected more insulin after receiving high glucose alert and experienced discomfort.Patient did not require any medical attention and was able to self resolve the event by eating food and taking glucose.

• 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: 18117215
• MDR Text Key: 327879844
• Report Number: 3009862700-2023-00246
• 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
• Report Date: 11/11/2023

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: 06/16/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP08962
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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): Other