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

Model Number 101368-67A

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

Patient Problems Unspecified Infection (1930); Pain (1994); Skin Inflammation/ Irritation (4545); Easy Bruising (4558)

Event Date 11/23/2018

Event Type  Injury  

Event Description

Senseonics was made aware of an incident wherein a patient was post implantation of eversense sensor developed skin irritation and bruising at the insertion site.Which led to pain at insertion site and swelling of the insertion site.The incident took place on (b)(6) 2018 directly after the sensor was implanted.The patient reported the incident on 23rd november 2018 after the sensor was removed on (b)(6) 2018.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The device was not defective.The sterilization record for this lot of sensor was reviewed and the sensor was sterilized as per specifications.Potential for development of skin irritation, bruising and/or pain are all known and anticipated potential adverse effects.There is no remedial action/corrective action/preventive action/field safety corrective action required in this case as the device is not defective.Potential for development of skin irritation, bruising and/or pain are all known and anticipated potential adverse effects.

• 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: 18268683
• MDR Text Key: 329744678
• Report Number: 3009862700-2023-00329
• 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: 05/10/2019
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4400-XX-302
• Device Lot Number: WP04171
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2018
• 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