MAUDE Adverse Event Report: SENSEONICS, INCORPORATED EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number 101967-710

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/14/2020

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Bleeding at insertion site is a known and anticipated potential adverse effect associated with sensor insertion.User was taken to the emergency room where the incision site was closed with 2-3 stitches and tegaderm.The heavy bleeding was likely due to the blood thinner the user had been taking since (b)(6) 2020.The suture resolved the bleeding, and the user was fine afterwards.

Event Description

Senseonics was made aware of an incident where the patient experienced excessive bleeding at the insertion site soon after insertion.The patient's wife found that the patient's shirt and trousers were full of blood, so she applied a pressure bandage over the insertion site.The bleeding continued, so the patient went to the emergency room.A surgeon at the er recommended removing the sensor, which the patient did not want, so the insertion site was sutured instead with tegaderm placed on top.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18488912
• MDR Text Key: 332588352
• Report Number: 3009862700-2023-00492
• Device Sequence Number: 1
• Product Code: QCD
• 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
• Report Date: 01/10/2024

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: 07/10/2020
• Device Model Number: 101967-710
• Device Catalogue Number: FG-4400-10-302
• Device Lot Number: WP06494
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2019
• 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 Sex: Male