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

Model Number 102208-750

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 10/21/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, senseonics was made aware of a hypoglycemia incident where patient complained of sensor inaccuracies.The incident happend on (b)(6) 2022.Patient reported that the eversense cgm system showed 100 mg/dl where as blood glucose (bg) reading was 38 mg/dl.Patient did not receive any low glucose alerts.Patient was symptomatic and felt dizzy.Patient's husband was able to assist her in resolving the issue.No medical intervention was required.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.The investigation analysis was performed on the user's in vivo sensor data synced by the user on the data management system (dms), which is the data cloud platform for eversense systems.Based on the investigation, the reported fingerstick measurement of 38 mg/dl was not entered in the system, thus the alleged mismatch could not be confirmed.A review of the sensor data showed that the user was experiencing a rapid change of glucose at the time of event, and the system asserted a predictive low glucose alert to warn the user of a potential hypoglycemia and to take action, as the sensor glucose was trending downwards.No further investigation was found necessary for this complaint.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 19009476
• MDR Text Key: 338980302
• Report Number: 3009862700-2024-00373
• 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: 03/31/2024

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: 03/02/2022
• Device Model Number: 102208-750
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 123340
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2021
• 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