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

Model Number 101967-750

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/06/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Bleeding at insertion site (while inserting or removing the sensor) is a known and anticipated potential adverse effect.This does not require any further investigation.User immediately went to the hospital where stitches were put to stop bleeding.The insertion site healed well after that.Patient/user is currently using eversense xl cgm system.There is no remedial action/corrective action/preventive action/field safety corrective action required.

Event Description

Senseonics was made aware of an incident where patient reported bleeding at the insertion site after it was removed on (b)(6) 2022.The patient visited the hospital because of this incident where the doctor needed to put 3 stitches.No medication was prescribed and the insertion wound healed later.

• 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: 18268026
• MDR Text Key: 329739386
• Report Number: 3009862700-2023-00759
• 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: 12/05/2023

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: 07/21/2022
• Device Model Number: 101967-750
• Device Catalogue Number: FG-4400-50-302
• Device Lot Number: WP08624
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2021
• 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): Hospitalization