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

Model Number 101967-950

Device Problem Difficult to Remove (1528)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On march 19, 2024, senseonics was made aware of an incident where the old sensor could not be removed during removal procedure on (b)(6) 2023.The sensor was inserted on (b)(6) 2023.The hcp was unable to remove the sensor.As per the information received by senseonics, the sensor was not properly palpable and an ultrasound was used to localize it.Another removal attempt will be made in future, but a date has not been provided.

• 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: 19140884
• MDR Text Key: 340560841
• Report Number: 3009862700-2024-00606
• 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
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP08965
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2022
• 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