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

Model Number 101967-750

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2021

Event Type  Injury  

Event Description

Senseonics was made aware of a false hypoglycemia event due to alleged sensor inaccuracies on (b)(6) 2021 at around 3:00 pm.The reported blood glucose (bg) value was 7.5 mmol/l and sensor glucose (sg) value was 3.3 mmol/l.User received low glucose alerts even though bg was in normal range and user had no symptoms at the time of incident.User did not require any medical attention.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The initial investigation was performed on the user synced glucose data in data management system (dms), which is a cloud platform for eversense systems.Based on the investigation analysis on user's data in data management system (dms), the system may have displayed temporary mismatch between the sensor reading and the fingerstick measurement on (b)(6) 2021.As the fingerstick measurement was not entered in the system, the analysis of the event is incomplete.Further analysis of the sensor diagnostics data (before and after the event) did not exhibit any anomaly with the sensor performance, however, the glucose plot did show noisy sensor readings.A transmitter reset was suggested for troubleshooting.The reset did not resolve the noise in the sensor readings and so the rma for sensor was authorized for further investigation as the cause for the noise in the sensor readings could not be determined.The returned sensor was investigated in-house which did not reveal any malfunction.This happens in some cases where the failure mode that presents in the body cannot be reproduced in the test environment.No further investigation was possible for this complaint.As part of resolution, the customer was given a sensor replacement.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 19008678
• MDR Text Key: 338979136
• Report Number: 3009862700-2024-00305
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491023360
• UDI-Public: 817491023360
• 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: 03/29/2024

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: 03/22/2022
• Device Model Number: 101967-750
• Device Catalogue Number: FG-4400-50-302
• Device Lot Number: WP08441
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2021
• 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