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

Model Number 102208-704

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); Convulsion/Seizure (4406); Vertebral Fracture (4520)

Event Date 09/20/2020

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Based on the investigation of the user's data in data management system (dms), the system might have missed hypoglycemic episode potentially due to transitory system inaccuracy.However, the system performance returned to normal shortly after the complaint date which was confirmed by customer.

Event Description

On (b)(6) 2020, senseonics was made aware of an instance where the user fell unconscious and had a seizure due to hypoglycemia.The emergency doctor was called and the user was taken to the hospital.During the seizure, she fractured her t9 vertebra.Sensor reading during the time of incident was 123 mg/dl and the user's blood glucose (bg) was 30 mg/dl.The user reported to have not received any low glucose alerts during the time of incident.

• 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: 18435796
• MDR Text Key: 331865732
• Report Number: 3009862700-2023-00506
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• 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: 01/03/2024

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: 10/02/2020
• Device Model Number: 102208-704
• Device Catalogue Number: FG-3400-04-001
• Device Lot Number: 116211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2019
• 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): Hospitalization