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

Model Number 102208-751

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.A return material authorization (rma) was issued to return the transmitter for evaluation.However, user did not want to replace the transmitter and hence it was not received for further analysis.Based on the initial escalation analysis, it was observed that there was an issue with the transmitter, so it was suggested that a transmitter reset be done to resolve the issue so the user could see the sensor glucose readings on the app.After a few tries, the user reported the app was displaying glucose readings.At the time of the event, the app was not displaying any sensor readings.The out of range low alerts asserted by the system may have been asserted incorrectly.The issue was remediated by performing a reset of the transmitter.No further investigation was possible as there was no data synced after (b)(6) 2021 for further analysis.

Event Description

Senseonics was made aware of an incident where patient complained that of receiving several low glucose (out of range) alerts starting at (b)(6) 2021 at around 7:45 am.User was not symptomatic and did not require any medical attention.User did not provide any sg or bg values.A transmitter reset was advised initially by the customer care.However, that did not resolve the issue.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 19008757
• MDR Text Key: 338979810
• Report Number: 3009862700-2024-00309
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): N
• 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: 03/29/2024

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 Expiration Date: 02/11/2022
• Device Model Number: 102208-751
• Device Catalogue Number: FG-3400-51-001
• Device Lot Number: 122601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other