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

Model Number 101967-950

Device Problem Difficult to Remove (1528)

Patient Problem Discomfort (2330)

Event Date 12/28/2023

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently waiting for additional information regarding next sensor removal attempt.The additional information will be provided in the supplemental report.

Event Description

On (b)(6) 2023, senseonics was made aware of an incident where the previous sensor could not be removed during removal procedure on (b)(6) 2023.The sensor could not be removed because it was hard to find.The hcp used x-ray examination to locate the old sensor and found it, but could not remove it.A new sensor, however, was inserted to continue using eversene e3 continuous glucose monitoring system (dms).The next removal attempt will be made at the time of next sensor exchange.

Manufacturer Narrative

A second attempt to extract the sensor was made on (b)(6) 2024, and the extraction was successful.B4.Date of this report: (b)(6) 2024.D6b.Explanted (b)(6) 2024.

• 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: 18592532
• MDR Text Key: 333898270
• Report Number: 3009862700-2024-00010
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023308
• UDI-Public: 817491023308
• 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,Followup
• Report Date: 02/08/2024

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: 10/12/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2022
• 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