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

Model Number 102096-67A

Device Problem Difficult to Remove (1528)

Patient Problem Discomfort (2330)

Event Date 02/13/2024

Event Type  Injury  

Manufacturer Narrative

According to the case notes, the hcp tried using an x-ray and ultrasound to locate the sensor and had no success.After making the incision, the sensor could still not be found.The next removal procedure was scheduled for (b)(6) 2024.After multiple follow-up attempts were made to gather more information regarding the second removal procedure, the user remained unresponsive.No further investigation is required.

Event Description

On (b)(6) 2024, senseonics was made aware of an adverse event where the user's sensor could not be removed on the first removal attempt.

Manufacturer Narrative

No further follow up attempts will be made as multiple attempts were made to gather more information.B4: date of this report 25 april 2024.G3: date received by the manufacturer? 28 march 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: 18909196
• MDR Text Key: 337731307
• Report Number: 3009862700-2024-00094
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022349
• UDI-Public: 817491022349
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/14/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP06680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2019
• 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 Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female