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

Model Number	102282-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fungal Infection (2419)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer attempted further follow-ups with the user on the resolution of the infection however currently no further information is available.
Event or Problem 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
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• MDR Report Key: 9268259
• Report Number: 3009862700-2019-00274
• Device Sequence Number: 11330884
• Product Code: QCD
• UDI-Device Identifier: 00817491021311
• UDI-Public: 00817491021311
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Model Number: 102282-500
• Device Catalogue Number: FG-6403-01-300
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR