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

Model Number 102208-500

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

Patient Problems Itching Sensation (1943); Skin Irritation (2076)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

The patient was prescribed with medication for irritation,itchiness and redness.Also,patient uses cortizone cream in the area that has caused the irritation.No further investigation is required.

Event Description

On (b)(6) 2020,senseonics was made aware of an incident where user experienced skin irritation,itchiness and redness due to adhesives.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown,, md
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown,, md
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, md
• MDR Report Key: 9780963
• MDR Text Key: 183780674
• Report Number: 3009862700-2020-00201
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• 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: 02/02/2020

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: 04/04/2020
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 113038
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2020
• Initial Date FDA Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR