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

Model Number 102208-704

Device Problem Connection Problem (2900)

Patient Problem Hypoglycemia (1912)

Event Date 06/03/2020

Event Type  Injury  

Event Description

Senseonics was made aware of an instance where the patient experienced hypoglycemia.Event occurred in the night and eversense was not in use because transmitter was not connected to the sensor.Patient did not require any help or medical attention.He took some sugar to raise his glucose level.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The user received a transmitter error alert due to which the transmitter disconnected from the sensor.Since eversense system was not in use during the hypoglycemia event, there cannot be any glucose related assert alerted.Moreover, patient did not require any medical attention/intervention during the incident as he self managed it by sugar intake after which he felt fine.The transmitter was investigated and it was found that the sensor calibration parameters from the sensor calibration file were missing in the transmitter diagnostics log file which resulted in transmitter error alert.

• 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: 18449851
• MDR Text Key: 332168187
• Report Number: 3009862700-2023-00471
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): N
• 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
• Report Date: 01/04/2024

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: 06/11/2020
• Device Model Number: 102208-704
• Device Catalogue Number: FG-3400-04-001
• Device Lot Number: 116800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2019
• 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