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

Model Number 101967-730

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Discomfort (2330); Fluid Discharge (2686)

Event Date 09/10/2020

Event Type  Injury  

Event Description

On february 24, 2021, senseonics was made aware of an instance where the patient experienced infection at the insertion site.The sensor was inserted on (b)(6) 2020, and the first removal attempt was made on (b)(6) 2020.As it was unsuccessful, another removal attempt was made on (b)(6) 2020, but was also unsuccessful.The user reported that during another removal attempt, the doctor observed a slight inflammation at the insertion site and pus.The patient was prescribed antibiotics.

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 was inserted on (b)(6) 2020, and it completed its 180-day life period successfully.Hence, there was no device malfunction associated with the incident.Due to tissue growth around the inserted area, the first few removal attempts were unsuccessful.Infection at the insertion site most likely occurred due to the wound from removal attempts.The patient was prescribed with antibiotics to treat the infected area.

• 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: 18488804
• MDR Text Key: 332587727
• Report Number: 3009862700-2023-00563
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: FI
• 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: 04/18/2020
• Device Model Number: 101967-730
• Device Catalogue Number: FG-4400-30-302
• Device Lot Number: WP06254
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2019
• 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