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

Model Number 102096-67A

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

Patient Problems Cellulitis (1768); Unspecified Infection (1930)

Event Date 05/30/2020

Event Type  Injury  

Manufacturer Narrative

This mdr is result of a retrospective review of complaints.Development of infection at the sensor insertion site is a known and anticipated potential adverse effect.User was prescribed with antibiotics to treat the infection and is doing fine.

Event Description

On (b)(6) 2020,senseonics was made aware of an adverse event where patient experienced cellulitis infection at sensor insertion site.

Manufacturer Narrative

H10 updated to development of infection at the sensor insertion site is a known and anticipated potential adverse effect.User was prescribed with antibiotics to treat the infection and is doing fine.B4 date of this report corrected to (b)(6) 2020.B5 updated to "on (b)(6) 2020,senseonics was made aware of an adverse event where patient experienced cellulitis infection at sensor insertion site:".G4 date received by manufacturer corrected to (b)(6) 2020.

Event Description

On (b)(6) 2020,senseonics was made aware of an adverse event where patient experienced cellulitis infection at sensor insertion site.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown, md
• MDR Report Key: 10330666
• MDR Text Key: 200593584
• Report Number: 3009862700-2020-00458
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• Combination Product (y/n): N
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

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: 05/02/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP06323
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 07/17/2020
• Supplement Dates FDA Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR