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

Model Number 102208-704

Device Problems Overheating of Device (1437); Battery Problem (2885)

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

Event Date 10/18/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Investigation of the returned transmitter revealed that battery was found to be defective.A corrective and preventive action (capa) was opened by senseonics which investigated the issue and the root cause was identified to be a deficiency in manufacturing process.User was given transmitter replacement as part of resolution.

Event Description

Senseonics was made aware of an incident where the transmitter exploded after keeping it for charging for 10 minutes.Customer said the transmitter fell down once a few months before this incident.Customer was not injured and no adverse events were associated with this incident.

• 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: 18998653
• MDR Text Key: 339126836
• Report Number: 3009862700-2024-00620
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2024

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: 07/25/2020
• Device Model Number: 102208-704
• Device Catalogue Number: FG-3400-04-001
• Device Lot Number: 115001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1