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

Model Number 101967-950

Device Problem Material Separation (1562)

Patient Problem Discomfort (2330)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer is currently performing evaluation and the results will be provided in the supplemental report.

Event Description

Senseonics was made aware of an incident where the sensor broke during the removal procedure on (b)(6) 2024.According to the hcp, the head of the sensor broke and a small piece of glass broke off when gripping the sensor, but it was recovered without any problem and the remaining piece of the sensor could be removed easily.All of the sensor and its pieces were removed.

Manufacturer Narrative

A visual inspection of the returned sensor showed that the end cap was separated from the sensor.According to the case information, all sensor pieces were successfully removed from the patient.The root cause for sensor breakage is usually excessive force on the removal clamps or grabbing an extremity of the sensor.Sensor breakage during removal is a known and anticipated potential adverse effect and eversense e3 user guide mentions about it under "risks and side effects".This incident does not require any further investigation.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 4248.H6.Investigation conclusions updated to 4310.

• Brand Name: EVERSENSE SENSOR
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR
• 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: 18861624
• MDR Text Key: 337184791
• Report Number: 3009862700-2024-00567
• Device Sequence Number: 1
• Product Code: QHJ
• 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,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/12/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other