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

Model Number 101967-750

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

Patient Problems Skin Infection (4544); Nodule (4551)

Event Date 10/16/2019

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where patient reported issues at the insertion site where sensor had been placed.They are aching, swelling and pusing.The wounds are not healing and opened again and again.Additionally he is having scars.The system is no longer in use since 1.5 years.

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.Patient mentioned that system is not in use since 1.5 years.Patient was reached out to gather more information like "were the symptoms started soon after insertion or after few days or after removal? ".However, user did not respond to the calls from customer care despite making multiple attempts.As a result, no further investigation was possible for this complaint other than reviewing the manufacturing records.Distributor left a voice mail saying that patient should contact his health care provider (hcp) and follow his advise for treatment.

• Brand Name: EVERSENSE SENSOR
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR
• 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: 19009135
• MDR Text Key: 338980106
• Report Number: 3009862700-2024-00240
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491023360
• UDI-Public: 817491023360
• 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: 03/30/2024

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: 07/11/2020
• Device Model Number: 101967-750
• Device Catalogue Number: FG-4400-50-302
• Device Lot Number: WP06497
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2021
• Initial Date FDA Received: 03/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2019
• 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