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

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 05/03/2020

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.The customer complaint could be verified via data management system (dms).Investigation of the data available on dms found no malfunction of system on date of event up until sensor replacement alert 3 days later.Investigation also showed the self diagnostics for system correctly triggered sensor replacement alert 3 days after the event.

Event Description

On may 14, 2020, senseonics was made aware of an instance where the patient experienced hypoglycemia.He reported that sensor showed 4.5 mmol/l whereas blood glucose meter showed 2.5 mmol/l.Target settings at that time was 5.5 mmol/l.Sensor value did not go below alert setting and hence did not trigger alert.She did not need any medical treatment.

• 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: 18965283
• MDR Text Key: 338431691
• Report Number: 3009862700-2024-00133
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: FI
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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