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 07/28/2021

Event Type  Injury  

Event Description

On (b)(6) 2021,senseonics was made aware of an incident where physician was unable to remove the sensor on the first attempt made on (b)(6) 2021.However,the sensor was successfully removed during the second removal attempt on (b)(6) 2021.

Manufacturer Narrative

The sensor was successfully removed during the second removal attempt on (b)(6) 2021.The high rate of inability to remove sensor was addressed under capa (b)(4) which was closed per (b)(4).No further investigation was found necessary.

• 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: 13300024
• MDR Text Key: 285350156
• Report Number: 3009862700-2022-00006
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• 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
• Report Date: 12/21/2021

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: 03/10/2021
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP07834
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2020
• 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: 36 YR
• Patient Sex: Female