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

Model Number 101967-950

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

Patient Problems Abscess (1690); Skin Infection (4544)

Event Date 04/10/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.The sensor is inserted by making a small incision and placing it under skin and potential for developing skin irritation/swelling/pain/ inflammation/infection around the insertion site is a known anticipated adverse event.The patient consulted hcp who decided to explant the sensor from the site to alleviate the symptoms.Antibiotics was prescribed to treat the infected area.This event does not require any further investigation.

Event Description

Senseonics was made aware of an incident where patient reported pain and infection at the insertion site.The customer reported that pus was coming from the insertion site.The customer consulted hcp who decided to remove the sensor from the arm to alleviate the symptoms and to treat with antibiotics.

• 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: 18117317
• MDR Text Key: 327888390
• Report Number: 3009862700-2023-00262
• 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
• Report Date: 11/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP08965
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2022
• 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