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

Model Number 102204-005

Device Problem Protective Measures Problem (3015)

Patient Problem Hypoglycemia (1912)

Event Date 11/15/2018

Event Type  Injury  

Event Description

Senseonics was made aware of an instance where in a patient using eversense cgm system went through a hypoglycemia event and reported that the eversense cgm system did not provide alert for low glucose on a consistent basis.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The patient has not reported any serious injuries.As per the complaint the user did mention that the eversense cgm system detected the hypoglycemia event accurately when the user was experiencing hypoglycemia and alerted the user.The user frustration was about the fact that he did not receive a repeat alert after the first alert was received when the hypoglycemia event occurred.So in case of this event to recur there is a very low probability of an injury to be likely due to the fact that the eversense cgm system detected the hypoglycemia event and alerted the user immediately when the user experienced the hypoglycemia event.

• 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: 18268282
• MDR Text Key: 329741562
• Report Number: 3009862700-2023-00328
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 12/05/2023

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: 02/07/2019
• Device Model Number: 102204-005
• Device Catalogue Number: FG-3400-XX-XXX
• Device Lot Number: 106259
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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