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

Model Number 102208-704

Device Problem Power Problem (3010)

Patient Problem Hypoglycemia (1912)

Event Date 09/25/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.User stated they had a blood glucose (bg) value of 44 mg/dl at the time of hypoglycemia event.However, the transmitter was not charged.As a result, the eversense xl cgm system could not assert any low glucose alerts.No further investigation was possible for this complaint as the system was basically not in use at the time of the event.User's husband assisted her to resolve the issue and no hospitalization was required.In addition, user's transmitter was replaced.However, no return material authorization (rma) was created as it was outside of warranty period.

Event Description

Senseonics was made aware of an incident where patient experienced a hypoglycemia event.The blood glucose (bg) was 44 mg/dl and the system could not assert any low glucose alerts because it was not in the use at the time of the event because transmitter was not charged.

• 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: 18318511
• MDR Text Key: 330382749
• Report Number: 3009862700-2023-00648
• 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: 12/13/2023

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: 09/15/2021
• Device Model Number: 102208-704
• Device Catalogue Number: FG-3400-04-001
• Device Lot Number: 120328
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2020
• 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