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

Model Number 102208-704

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2022

Event Type  malfunction  

Event Description

Senseonics was made aware of an incident where patient complained that transmitter got extremely hot while charging and would not turn on.Incident did not lead to any injuries.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Transmitter was requested to be returned for evaluation.The transmitter was initially tested for visual inspection which did not reveal any anomalies.The unit was then tested for functional verification and it passed all the tests.As a result, the customer complaint could not be confirmed or the problem could not be reproduced in lab testing.

• 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: 19009360
• MDR Text Key: 339010186
• Report Number: 3009862700-2024-00319
• 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: 03/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/06/2021
• Device Model Number: 102208-704
• Device Catalogue Number: FG-3400-04-001
• Device Lot Number: 121136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2020
• 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