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

Model Number 102282-500

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

Patient Problem Fungal Infection (2419)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer attempted further follow-ups with the user on the resolution of the infection however currently no further information is available.

Event Description

On august 19th, 2019, senseonics was made aware of an incident where the user developed an infection at the insertion site.

• Brand Name: EVERSENSE ADHESIVE PATCHES
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: sachin thanawala ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 9268259
• MDR Text Key: 165639034
• Report Number: 3009862700-2019-00274
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021311
• UDI-Public: 00817491021311
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/03/2019

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 Model Number: 102282-500
• Device Catalogue Number: FG-6403-01-300
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 14 YR