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

Model Number 101368-67A

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

Patient Problems Pain (1994); Discomfort (2330)

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.The device was not defective.A review of the device's manufacturing records indicated that the sensor lot met all specifications for release and was sterilized as per specifications.Pain or discomfort is a known and anticipated potential adverse effect.Patient felt fine after removing the sensor.The sensor was removed at the request of the patient.A new sensor was inserted after the wound healed.The patient reports that he is feeling fine with the new sensor.

Event Description

On september 19, 2019, senseonics was made aware of an event where a user of the eversense sensor reported pain at the insertion site that continued for 4 weeks post insertion; the sensor was removed on (b)(6) 2019.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18415814
• MDR Text Key: 331579176
• Report Number: 3009862700-2023-00406
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 12/28/2023

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: 11/07/2019
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4400-XX-XXX
• Device Lot Number: WP05026
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2018
• 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 Outcome(s): Other