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

Model Number 102096-81A

Device Problem Difficult to Remove (1528)

Patient Problem Discomfort (2330)

Event Date 01/06/2024

Event Type  Injury  

Manufacturer Narrative

This mdr is a result of retrospective review of complaints.According to the case notes, the area was palpable, and the transmitter was utilized to localize the area of the sensor but the sensor could not be removed.The next removal procedure is scheduled for (b)(6) 2024.

Event Description

On january 12, 2024, senseonics was made aware of an adverse event where the hcp could not remove the sensor from the user's arm on the first attempt.

Manufacturer Narrative

Sensor was successfully removed on (b)(6) 2024.No further investigation is required.B4.Date of this report 25 april 2024.D6b.Explanted date updated to (b)(6) 2024.G3.Date received by the manufacturer? 23 feb 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: 18764446
• MDR Text Key: 336050110
• Report Number: 3009862700-2024-00070
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022950
• UDI-Public: 817491022950
• 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,Followup
• Report Date: 04/25/2024

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: 12/22/2023
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: WP09237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2023
• 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: 40 YR
• Patient Sex: Female