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

Model Number 101967-950

Device Problem Material Separation (1562)

Patient Problem Pain (1994)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing evaluation and the results will be provided in a supplemental report.

Event Description

Senseonics was made aware of an incident where the sensor broke during removal procedure.The transparent end piece of the sensor became came loose during removal, while trying to grab the sensor with the clamp.The hcp, however, was able to completely remove the sensor.

Manufacturer Narrative

Per case notes, the sensor was broken during removal into two pieces and the endcap was separated from the sensor.The hcp was able to remove both the pieces.The rma was authorized for the removed sensor but not received.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.The hcp was able to remove all fragments of the broken sensor.No further resolution was found necessary.B4: date of this report updated to 29 january 2024.G3: date received by manufacturer updated to 04 january 2024.H3: device evaluated by manufacturer? not returned to manufacturer.H6: investigation findings updated to 3221.H6: investigation conclusions updated to 4311.

• 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: 18314270
• MDR Text Key: 330326021
• Report Number: 3009862700-2023-00828
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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