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

Model Number 102208-750

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 08/14/2021

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where patient experienced a hyperglycemia event and complained of not receiving high glucose alerts because sensor showed normal values.The sensor glucose (sg) reading was 130 mg/dl where as the blood glucose was 300 mg/dl.Patient did not require any medical attention or intervention and was able to resolve the problem herself.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Transmitter was not requested to be returned for evaluation because it was still being used by the customer.Investigation was performed on the customer's data available on the data management system.The customer's complaint could not be confirmed.Review of in-vivo data did not confirm the customer's stated discrepancy between sg and bg values on 14th august and mard (mean absolute relative difference between bg and sg) for week of event date was found to be acceptable.

• 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: 19008156
• MDR Text Key: 338980470
• Report Number: 3009862700-2024-00236
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491023087
• UDI-Public: 817491023087
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 03/29/2024

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: 01/04/2022
• Device Model Number: 102208-750
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 121978
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/04/2021
• 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