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

Model Number 101967-950

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

Patient Problems Abscess (1690); Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Date 07/03/2023

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 symptoms were first observed on (b)(6) 2023 and the patient consulted hcp.The hcp decided to explant the sensor from the site to alleviate the symptoms.Antibiotics was prescribed to treat the infected area.After taking antibiotics, the infection healed completely.The patient was also re-inserted with another sensor to continue using eversense e3 cgm system.This event does not require any further investigation.

Event Description

Senseonics was made aware of an incident where patient reported infection at the insertion site.The sensor was inserted on (b)(6) 2023 and the symptoms was first observed on (b)(6) 2023.The customer had symptoms such as pain, swelling and redness.Additionally, the customer reported that the insertion site opened and a lot of pus came out.The customer visited hcp and because of severe infection, the sensor was removed from the customer's arm and was treated with amoxicillin antibiotics.The customer was also re-inserted with another sensor which is currently working as expected.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING 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: 18117338
• MDR Text Key: 327880179
• Report Number: 3009862700-2023-00278
• 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: 10/12/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other