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

Model Number 102208-922

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 12/30/2022

Event Type  Injury  

Event Description

Senseonics was made aware of a hyperglycemia event and patient complained of not receiving high glucose alert.The event as reported by the patient, happened on (b)(6) 2022 at 9:11 am.Patient mentioned that the sensor glucose (sg) reading was 194 mg/dl and the blood glucose (bg) reading was 305 mg/dl.Patient self treated by administering insulin.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The 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.Based on the investigation analysis, the reported mismatch between blood glucose (bg) and sensor glucose (sg) on (b)(6) 2022 was confirmed.The bg value was taken during a period of rapid change in glucose.This can contribute to the mismatch between bg and sg.During a period of such rapid changes in the glucose, the sensor values can lag considerably behind the fingerstick measurements.As per manufacturer's recommendation (eversense user guide), the best calibration practice is to not calibrate during the period of rapid glucose changes.The system did not assert a high glucose alert at the exact time of the event, but the user did receive one at 8:36 am when the sg value reached 191 mg/dl - 35 minutes before the reported event.Based on the analysis of the diagnostic upload, the high glucose alert repeat interval was set to 120 minutes (2 hours), therefore the alert was not asserted at 9:11 am as the alert was not cleared until 10:36 am.The overall system performance before and after the event was reviewed, and it was performing within acceptable parameters.No further resolution was found necessary for this complaint.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 18117216
• MDR Text Key: 327887543
• Report Number: 3009862700-2023-00245
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: PL
• 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: 07/08/2023
• Device Model Number: 102208-922
• Device Catalogue Number: FG-3500-22-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other