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

Model Number 102208-600

Device Problem Imprecision (1307)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/30/2023

Event Type  Injury  

Manufacturer Narrative

This mdr is a result of retrospective review of complaints.The user followed up with the clinic two days after the insertion procedure and was advised to follow up with her primary care physician.The primary care physician took note of the bleeding and advised the user to make a follow-up appointment on (b)(6) 2023, if the bleeding did not stop within a few days.The user confirmed the bleeding stopped on (b)(6) 2023.No further resolution was found necessary for this complaint.

Event Description

On october 30, 2023, senseonics was made aware of an adverse event where the user visited the inserting clinic two days post insertion because the insertion site continued to bleed through the gauze and bandage.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 18264070
• MDR Text Key: 329670941
• Report Number: 3009862700-2023-00822
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 00817491022912
• Combination Product (y/n): Y
• 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: 12/04/2023

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: 07/08/2024
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 139384
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2023
• 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 Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female