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

Model Number 102096-67A

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

Patient Problems Rash (2033); Discomfort (2330)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

The user was prescribed with medication( zyrtec twice a day; for flares, hydroxyzine).No further investigation is required.

Event Description

On (b)(6) 2020,senseonics was made aware of an incident where user reports a condition of generalized hives located on the arms but also to the other extremities before the insertion.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE 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: 9742768
• MDR Text Key: 183757183
• Report Number: 3009862700-2020-00134
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• 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: 01/24/2020

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: 07/10/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP06783
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• 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 Age: 28 YR