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

Model Number 102208-704

Device Problem Excessive Heating (4030)

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

Event Date 07/03/2020

Event Type  malfunction  

Event Description

Senseonics was made aware of an instance where patient reported that the transmitter was exploded on the arm, right after loading and placing the transmitter.Patient did not get injured because of this incident and hence did not require any medical attention/intervention.Transmitter battery was not lasting as expected and patient was charging it thrice a day.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Transmitter 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 authorized a transmitter replacement.As part of the corrective action plan, the quarantined transmitters identified in containment step of corrective and preventative action (capa) will undergo additional testing and classification based on battery lots used in the transmitters, to determine which of those transmitters can be released to the field.

• 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: 18764596
• MDR Text Key: 336801015
• Report Number: 3009862700-2024-00140
• 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: 02/22/2024

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 Expiration Date: 04/24/2020
• Device Model Number: 102208-704
• Device Catalogue Number: FG-3400-04-001
• Device Lot Number: 113450
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2019
• 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