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

Model Number 102208-005

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Based on the investigation there was no malfunction found with the returned transmitter.No further investigation was found necessary for this complaint as part of resolution user received new transmitter.

Event Description

Senseonics was made aware of an instance wherein a patient using the eversense cgm system went through a hyperglycemia event and reported that the eversense cgm system did provide an alert through the medical mobile app but was not alerted through the eversense transmitter.The patient reported she does not remember the eversense sensor glucose value, neither does she remember the date/time of the event.The patient did not require medical attention.

• Brand Name: EVERSENSE 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
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18405544
• MDR Text Key: 331477427
• Report Number: 3009862700-2023-00379
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• 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: 12/27/2023

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: 08/17/2019
• Device Model Number: 102208-005
• Device Catalogue Number: FG-3400-XX-XXX
• Device Lot Number: 109106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2018
• 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