MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SMART TRANSMITTER; IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER

Model Number 102208-705

Device Problem Battery Problem (2885)

Patient Problem Hypoglycemia (1912)

Event Date 11/11/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.A review of the data management system (dms) did not show any sensor glucose (sg) value during the time of incident because it was never recorded as the smart transmitter was not connected to the app.It was turned off because battery was not lasting charge as expected.The transmitter was requested to be returned for further evaluation.However, the product was never received.As part of resolution, a replacement transmitter was given to the user.No further investigation was possible for this complaint.

Event Description

Senseonics was made aware of an incident where patient reported a hypoglycemia event because and complained of not being notified by the smart transmitter because it was turned off due to battery not lasting as expected (battery issues).Patient reported that the blood glucose was 60 mg/dl.Patient had symptoms such as exhaustion, sweating ad low visibility.However, she did not require any medical attention or intervention because she has diabetes since childhood and knows how to manage the hypoglycemia.She took sugar orally and got stable again.

• Brand Name: EVERSENSE SMART TRANSMITTER
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER
• 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: 19009317
• MDR Text Key: 338980589
• Report Number: 3009862700-2024-00282
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 03/31/2024

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 Model Number: 102208-705
• Device Catalogue Number: FG-3400-05-001
• Device Lot Number: 120259
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 03/31/2024
• 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