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 07/27/2023

Event Type  Injury  

Manufacturer Narrative

Per case notes, the sensor was palpable before incision and locatable with transmitter, however, the hcp could not retrieve the sensor.The user was sore after the procedure and had bandages over the incision.The user was advised to wait two weeks for their incision to heal and is waiting to get an appointment for the next removal attempt.No date for the second removal attempt has been confirmed.The sensor removal status will be updated in the supplement report when the information becomes available.

Event Description

On (b)(6) 2023, senseonics was made aware of an adverse event where the physician was unable to remove the sensor from the user's arm on the first attempt.

Manufacturer Narrative

Despite multiple follow up attempts with the user the removal status of the sensor could not be confirmed.No further investigation was found necessary.Date of this report updated to 10 january 2024.Date received by manufacturer updated to 08 september 2023.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 17590878
• MDR Text Key: 321596011
• Report Number: 3009862700-2023-00169
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/12/2023
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: WP08882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2022
• 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
• Patient Age: 37 YR
• Patient Sex: Male