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

Model Number 102812-81A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Pain (1994); Swelling/ Edema (4577)

Event Date 01/05/2023

Event Type  Injury  

Event Description

On 06 january 2023, senseonics was made aware of an adverse event where user had a lot of pain on the surface of the arm where the sensor was inserted and having the symptoms of swelling and bruising.User had pain when removing jacket and went to see the health care professional.

Manufacturer Narrative

Pain at insertion site is a known and anticipated potential adverse effect, which does not require additional investigation.Symptoms lead to the removal of the sensor and user was prescribed with lidocaine cream by health care professional.User's symptoms were improved after using the cream.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.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: 16301592
• MDR Text Key: 308824697
• Report Number: 3009862700-2023-00030
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022974
• UDI-Public: 817491022974
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/26/2023
• Device Model Number: 102812-81A
• Device Catalogue Number: FG-7202-00-301
• Device Lot Number: WP09016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2022
• 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: 47 YR
• Patient Sex: Prefer Not To Disclose