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

Model Number 102204-005

Device Problem Device Alarm System (1012)

Patient Problem Hypoglycemia (1912)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The patient complained that the transmitter did not vibrate at the time of incident even though alert was received on the mobile device.To further evaluate the issue, the transmitter was requested to be returned for investigation.The investigation of the returned transmitter did not reveal any malfunction as it passed all the functional tests including the vibration test.Thus, the customer complaint could not be confirmed.

Event Description

Senseonics was made aware of an instance where a patient using the eversense cgm system went through a hypoglycemia event and reported that the eversense cgm system provided an alert on the application for the low glucose reading, but the eversense transmitter did not vibrate.The user did confirm the alerted sensor glucose reading with her blood glucose meter reading.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 18288857
• MDR Text Key: 329995314
• Report Number: 3009862700-2023-00373
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/07/2023

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: 08/18/2019
• Device Model Number: 102204-005
• Device Catalogue Number: FG-3400-XX-XXX
• Device Lot Number: 109119
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other