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

Model Number 102208-914

Device Problem Device Alarm System (1012)

Patient Problem Hypoglycemia (1912)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

Initial investigation was performed on data management system (dms) which is a cloud platform for eversense systems.A review of the glucose data confirmed the value of 2,8 mmol/l on 1 december 2023 at 7:33 pm and at that time the patient received alerts on their mobile device.However, the vibration alerts from the transmitter was not received and senseonics has requested transmitter to be sent back for further evaluation.Manufacturer is currently performing evaluation and the results will be provided in the supplemental report.

Event Description

On (b)(6) 2023, senseonics was made aware of a hypoglycemia event where the patient complained of not receiving vibration alerts from the transmitter.The patient reported that the sensor glucose (sg) value was 2,9 mmol/l at the time of incident, but the patient did not remember the time.The patient did not measure the blood glucose (bg) value as well.The patient did not require any medical attention and was able to self resolve by eating.

Manufacturer Narrative

Initial investigation was performed on data management system (dms) which is a cloud platform for eversense systems.A review of the glucose data confirmed the value of 2,8 mmol/l on (b)(6) 2023 at 7:33 pm and at that time the patient received alerts on their mobile device.However, the vibration alerts from the transmitter was not received and senseonics requested transmitter to be sent back for further evaluation.Investigation of the returned transmitter revealed that vibrations are sometimes weaker then expected which was due to an internal defect in transmitter vibe (lra) motor.As part of resolution, a new transmitter was given to the customer which is working as expected.No further investigation was found necessary for this complaint.B4.Date of this report on (b)(60 2024 g3.Date received by the manufacturer? 19 jan 2024 h3.Device evaluated by manufacturer? yes h6.Type of investigation updated to 10 h6.Investigation findings updated to 180 h6.Investigation conclusions updated to 4307.

• 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: 18451826
• MDR Text Key: 332181290
• Report Number: 3009862700-2023-00837
• 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,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/02/2024
• Device Model Number: 102208-914
• Device Catalogue Number: FG-3500-04-101
• Device Lot Number: 134895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2023
• 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