MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SMART TRANSMITTER; IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER

Model Number 102208-750

Device Problems Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.No materials were available for product testing and there was no glucose data between august 12 to 24 on data management system (dms), due to issues with the transmitter.Since there was no available data on august 20, no further investigation was possible for this complaint.The reason why no data was available on dms was because of the issue with pairing the transmitter to the phone.User was assisted with troubleshooting the issue, but it could not be resolved.Transmitter replacement was not offered because it was outside of warranty period.User got a new transmitter from the clinic to continue using the eversense xl cgm system.User resolved the hypoglycemia incident by consuming oral glucose.

Event Description

Senseonics was made aware of an incident where patient experienced a hypoglycemia event and the system did not alert the user because the transmitter was not working.Patient had an issue with pairing the transmitter and at the time of incident, she was still awaiting for the assistance from the customer care.

• Brand Name: EVERSENSE SMART TRANSMITTER
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER
• 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: 18995105
• MDR Text Key: 338883945
• Report Number: 3009862700-2024-00234
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: AN
• 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: 03/28/2024

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: 02/28/2022
• Device Model Number: 102208-750
• Device Catalogue Number: FG-3400-54-001
• Device Lot Number: 122516
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2021
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2021
• 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