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 Problem Itching Sensation (1943)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

This mdr is result of a retrospective review of complaints.The patient decided to remove the eversense sensor due to the issue and not being reinserted with a new sensor.No further investigation was found necessary for this complaint.

Event Description

On (b)(6) 2019,senseonics was made aware of an adverse event where user has extreme inconsistent itching and decided to remove the sensor.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR 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: 10022482
• MDR Text Key: 189835255
• Report Number: 3009862700-2020-00306
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/04/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP05689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2019
• 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: 50 YR