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

Model Number 102620-81A

Device Problem Material Separation (1562)

Patient Problem Discomfort (2330)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

The sensor broke in half, into two pieces.All fragments of the broken sensor were successfully removed during the first removal attempt on (b)(6) 2024.The rma was authorized for return of the broken sensor.The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On february 27, 2024, senseonics was made aware of an adverse event where the user's sensor broke into two pieces during the removal procedure.

Manufacturer Narrative

Visual inspection of the returned sensor indicated that the sensor was broken into two halves during the removal procedure.All fragments of the broken sensor were successfully removed from the user.The breakage was most likely due to excessive force applied by the removal clamps or grabbing an extremity of the sensor.In some cases, the user's tissue may encapsulate the sensor, making it difficult to remove.The doctor may then attempt excessive force on the clamps and risk fracturing the sensor.No further resolution was found necessary for this complaint.B4.Date of this report updated to 11 april 2024.G3 date received by the manufacturer ? 11 april 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: 18989883
• MDR Text Key: 338743064
• Report Number: 3009862700-2024-00573
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022967
• UDI-Public: 817491022967
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/03/2023
• Device Model Number: 102620-81A
• Device Catalogue Number: FG-7201-00-301
• Device Lot Number: WP09134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• 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: 55 YR
• Patient Sex: Female