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

Model Number 102208-904

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 12/10/2022

Event Type  Injury  

Event Description

On december 15, 2022, senseonics was made aware of a hypoglycemia incident and the patient complained of sensor inaccuracies.The incident happened on (b)(6) 2022.Patient sent a screenshot according to which the sg value was 11.2 mmol/l.Patient said the bg meter gave significantly lower result at that time and the alerts were not received from the cgm system.

Manufacturer Narrative

This report is being submitted retrospectively as part of an 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.The investigation analysis of the reported event showed that the blood glucose (bg) fingerstick measurements were not entered as calibrations, but rather as manual glucose event entries.The system is designed to adjust glucose calculations based on the calibration entries and not on manual glucose event entries.The manual bg entries are for event logging and will not be considered by the system as calibration entries.Furthermore, during the sensor data review, it was also suspected that user was not calibrating properly.The user was likely using estimated sg values displayed by the eversense system for calibration entries, rather than using bg values from actual fingerstick measurements.Entering anything other than a true bg value can disrupt the calibration and lead to significant deviations in the sensor readings.The overall sensor performance was within expectations and there was no malfunction of the system.The differences between sg and bg values observed by the user were due to the improper calibrations.A feedback to the user was provided to ensure correct fingerstick measurements are entered at all the times to avoid deviation in the sensor readings.

• 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: 19009481
• MDR Text Key: 338980499
• Report Number: 3009862700-2024-00377
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491023070
• UDI-Public: 817491023070
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 11/22/2022
• Device Model Number: 102208-904
• Device Catalogue Number: FG-3400-53-101
• Device Lot Number: 127956
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2021
• 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