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

Model Number 102208-005

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 09/22/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, senseonics was made aware of an adverse event where the patient was hospitalized due to a hyperglycemic event.It was reported that the patient's transmitter vibrated at the time of event.The patient was given two bottles of venous infusion at the hospital.The patient is doing fine now.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Based on the investigation, it cannot be determined if there was a malfunction of the system as no further responses were received from the user.It was checked in data management system (dms) to ensure that the system did assert hyperglycemia alerts successfully when the sensor glucose reading crossed the alert threshold, before and after the event date.The user received necessary medical treatment to subside the symptoms of hypoglycemia event and is feeling fine now.

• 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: 18415815
• MDR Text Key: 331577462
• Report Number: 3009862700-2023-00408
• 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: 12/28/2023

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: 12/01/2019
• Device Model Number: 102208-005
• Device Catalogue Number: 102208-005
• Device Lot Number: 109887
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2018
• 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): Hospitalization