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 12/07/2023

Event Type  Injury  

Manufacturer Narrative

The next removal attempt for the separated piece is scheduled for the next removal attempt or earlier if the piece begins to show before then.The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On december 7, 2023, senseonics was made aware of an adverse event where a sensor broke in half during the removal procedure and only one piece could be recovered.The hcp prescribed the user with keflex to prevent infection due to the remaining piece.

Manufacturer Narrative

Visual inspection showed the sensor was fractured and only one of the fragments was returned to senseonics.Per case notes, the sensor was broken during removal into two pieces and the hcp could only retrieve one of the pieces.The hcp and the customer will schedule to have the remaining part of the broken sensor removed later this year, as the first attempts were not successful.The root cause for sensor fracture is usually excessive force applied by the removal clamps or grabbing an extremity of the sensor.In some cases, the patient's tissue at insertion sites may encapsulate the sensor, obstructing its removal.The doctor may then attempt excessive force on the clamps and risk fracturing the sensor.D9 device available for evaluation? yes, 08 jan 2024.G3.Date received by the manufacturer? 19 jan 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: 18460439
• MDR Text Key: 332253407
• Report Number: 3009862700-2023-01031
• Device Sequence Number: 1
• Product Code: QHJ
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/04/2023
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: WP09023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2022
• 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: 62 YR
• Patient Sex: Male