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

Model Number 102208-005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoglycemia (1912)

Event Date 08/27/2019

Event Type  Injury  

Event Description

On (b)(6) 2023, senseonics was made aware of event where the user experienced a hypoglycemic event and lost consciousness.On (b)(6), the user had readings of 18,5 mmol/l and rising at 11:30am.The user injected fast acting insulin and 30 minutes later the patient lost consciousness.His wife called an ambulance and he was admitted to icu where he stayed for one day.The user was supposed to stay longer but the patient left the hospital at his own risk.He is feeling fine now.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Based on the available information, there was no malfunction observed within the system.No further follow up from the patient was received to make further investigation.The patient recovered and is feeling fine.

• 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: 18415816
• MDR Text Key: 331577494
• Report Number: 3009862700-2023-00405
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• 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: 05/29/2019
• Device Model Number: 102208-005
• Device Lot Number: 107693
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2018
• 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