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 09/23/2022

Event Type  Injury  

Manufacturer Narrative

During the removal procedure the sensor broke off and part of the sensor is still in the patient's arm.Health care professional want to remove it but user had hip surgery and can't lay on her side for 12 weeks.No date for next appointment was provided.No more follow up attempts will be made as multiple attempts were made to gather information.

Event Description

On september 26th 2022, senseonics was made aware of an adverse event where during the removal procedure the sensor broke off and part of the sensor is still in the patient's arm.Health care professional want to remove it but user had hip surgery and can't lay on her side for 12 weeks.No date for next appointment was provided.

• 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: 15667635
• MDR Text Key: 302356039
• Report Number: 3009862700-2022-00168
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2023
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: WP08813
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2022
• 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 Age: 42 YR
• Patient Sex: Female