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

Model Number 102096-81A

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

Patient Problems Unspecified Infection (1930); Pain (1994); Fluid Discharge (2686)

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

Despite multiple follow up attempts with the user, the status and details of the infection at the insertion site could not be confirmed.No further investigation is required.

Event Description

On (b)(6) 2024, senseonics was made aware of an adverse event where the user reported mild pain and yellow discharge at the insertion site.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18773790
• MDR Text Key: 336178216
• Report Number: 3009862700-2024-00084
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/13/2024
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: WP09278
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/09/2023
• 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: 26 YR
• Patient Sex: Female