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

Model Number 102812-67A

Device Problem Difficult to Remove (1528)

Patient Problem Discomfort (2330)

Event Date 01/05/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturer will provide the results with a supplemental report.

Event Description

On january 17th 2022, senseonics was made aware of an incident where the physician was unable to remove the sensor from the users left arm on the first attempt.

Manufacturer Narrative

Inability to remove sensor is a known and anticipated potential adverse effect, which does not require additional investigation and vigilance reporting per ntf-0319.The next removal appointment was scheduled for (b)(6) 2022.A follow up was made to ask if the sensor was removed.However, no response has been received as of yet.

• 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: 13423028
• MDR Text Key: 284867584
• Report Number: 3009862700-2022-00019
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022523
• UDI-Public: 00817491022523
• 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: 01/17/2022

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: 04/15/2022
• Device Model Number: 102812-67A
• Device Catalogue Number: FG-4202-00-301
• Device Lot Number: WP08306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/02/2022
• Supplement Dates Manufacturer Received: 01/17/2022
• Supplement Dates FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2021
• 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: 64 YR
• Patient Sex: Female