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

Model Number 102812-81A

Device Problem Difficult to Remove (1528)

Patient Problem Discomfort (2330)

Event Date 01/13/2023

Event Type  Injury  

Manufacturer Narrative

Per the case notes, there were several calls made to gather more information regarding the failed sensor removal.Despite multiple follow up attempts with the user the removal status of the sensor could not be confirmed, but the case notes did confirm that the user was currently using the system with up to date information.No further investigation was found necessary.

Event Description

On (b)(6) 2023, senseonics was made aware of an adverse event where the physician was unable to remove the old sensor and inserted the new sensor in the same arm.Due to the user having two sensors in the same arm and not being able to turn the transmitter off, customer care suggested that the user get the old sensor removed.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• 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: 16359914
• MDR Text Key: 309366872
• Report Number: 3009862700-2023-00031
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022974
• UDI-Public: 00817491022974
• 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
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2023
• Device Model Number: 102812-81A
• Device Catalogue Number: FG-7202-00-301
• Device Lot Number: WP08813
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2022
• 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 Age: 55 YR
• Patient Sex: Female