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

Model Number 102208-750

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); Shaking/Tremors (2515)

Event Date 06/25/2021

Event Type  Injury  

Event Description

On july, 13, 2021, senseonics was made aware of an incident where patient experienced a hypoglycemia event on (b)(6) 2021.Patient felt trembling, cold sweat, unfocused.User complained that she complained to have received low glucose alerts.User was able to resolve the incident by herself by eating something and then injecting insulin.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Based on the investigation analysis, it was found that the captured events were reported after the system retired the sensor.Upon, review of the system, it was found that the system correctly asserted the sensor replacement early, following the events of sensor inaccuracy, due to low measurement of sensor performance (msp) and poor sensor performance.Even though user reported the events after sensor replacement alert, one suggestion can be shared with the user to change the low alerts levels upon discussing the matter with their hcp (health care provider) as the user mentioned feeling hypo when glucose range was between 90 mg/dl and 75 mg/dl.

• 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: 18976386
• MDR Text Key: 338550900
• Report Number: 3009862700-2024-00216
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023087
• UDI-Public: 817491023087
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2020
• Device Model Number: 102208-750
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 116224
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2019
• 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