MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number 102096-81A

Device Problem Material Separation (1562)

Patient Problem Discomfort (2330)

Event Date 12/19/2023

Event Type  Injury  

Event Description

On december 19, 2023, senseonics was made aware of an adverse event where a sensor broke during the removal procedure.

Manufacturer Narrative

When the hcp first pulled the sensor out with the clamp, only the bottom part with the ring was removed.When the hcp went back in to remove the other piece, some dark tissue was removed before removing the rest of the sensor.The sensor was removed in its entirety.The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Manufacturer Narrative

Sensor was received, a visual inspection showed that the end cap was separated from the sensor.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.B4.Date of this report 01 march 2024.G3.Date received by the manufacturer? 01 feb 2024.H3.Device evaluated by manufacturer?yes.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• 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: 18531968
• MDR Text Key: 333087138
• Report Number: 3009862700-2024-00055
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022950
• UDI-Public: 817491022950
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

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: 03/28/2023
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: WP08822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2022
• 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
• Patient Age: 65 YR
• Patient Sex: Female