MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SMART TRANSMITTER; IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER

Model Number 102208-751

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 06/05/2022

Event Type  Injury  

Event Description

Senseonics was made aware of a hyperglycemia event and user complained of sensor inaccuracies.User reported that the event happened on (b)(6) 2022 at around 3 pm.The measured blood glucose was 237 mg/dl and the sensor reading was 110 mg/dl.User did not receive any high glucose alerts.User was symptomatic, but did not want to provide information regarding self treatment, medical treatment or if hospitalization was required.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The transmitter was not requested to be returned for evaluation as it was still being used by the user.The investigation was performed on the user's data available in data management system.The investigation confirmed the reported mismatch between bg and sg on (b)(6) 2022 as reported.Investigation revealed temporary noise in optical channel and customer complained of infection at insertion site which could have likely contributed to the reported mismatch.

• Brand Name: EVERSENSE SMART TRANSMITTER
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER
• 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: 19009411
• MDR Text Key: 338980421
• Report Number: 3009862700-2024-00354
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 03/31/2024

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: 10/07/2022
• Device Model Number: 102208-751
• Device Catalogue Number: FG-3400-51-001
• Device Lot Number: 127178
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other