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

Model Number 101967-710

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

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an 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/inflammation/infection at the insertion site is a known anticipated adverse event.Patient visited doctor on (b)(6) 2020 who prescribed an antibiotic.However, the infection got worse and over the weekend, the incision opened, and pus discharged.Patient visited doctor again who removed sensor on (b)(6) 2020.

Event Description

On (b)(6) 2020, senseonics was made aware of an instance where the patient developed infection at insertion site.The insertion area was swollen, and red.The patient visited the doctor on (b)(6) 2020 who prescribed an antibiotic.However, the infection got worse and over the weekend, the incision opened, and pus discharged.The patient visited the doctor again who advised to remove sensor.

• 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: 18484696
• MDR Text Key: 332561547
• Report Number: 3009862700-2023-00513
• 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: 10/24/2020
• Device Model Number: 101967-710
• Device Catalogue Number: FG-4400-10-302
• Device Lot Number: WP07706
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2019
• 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