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

Model Number 102208-905

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 07/12/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The investigation was performed on the user synced glucose data on data management system (dms), which is an eversense cloud platform.Based on the investigation analysis, the reported mismatch was confirmed and the low glucose alert was not asserted at the time of incident because the sg value did not cross below the low glucose alert setting of 70 mg/dl.A review of the system performance via a dms analysis did not reveal any abnormalities and the system was working within expectations.Overall, the blood glucose (bg) values entered as calibrations fit sensor glucose (sg) trends well, with some occasional differences due to lag and calibrations that were entered during the period of rapid glucose changes.There were many gaps in the glucose data due to transmitter disconnections and calibrations were entered after the gap.This is not the recommended usage of the system.The customer was recommended to use the system consistently so that the system would adjust its glucose according to entered calibrations.The customer was also recommended to calibrate when the glucose is stable to minimize inaccuracies.The customer is currently using the system with up to date glucose information and has not reported any additional concerns.No further investigation was found necessary for this complaint.

Event Description

Senseonics was made aware of a customer experiencing a hypoglycemia event on (b)(6) 2023 at 9:38 pm.The customer reported that the measured blood glucose (bg) value was 58 mg/dl where as the sensor glucose (sg) reading was 99 mg/dl.The customer did not receive a low glucose alert because the sg value did not cross below the low alert threshold which was set at 70 mg/dl.The customer self resolved the incident by eating some sugar.Th customer did not require any medical attention.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING 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: 18117342
• MDR Text Key: 327888396
• Report Number: 3009862700-2023-00279
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 11/12/2023

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: 12/12/2023
• Device Model Number: 102208-905
• Device Catalogue Number: FG-3500-05-001
• Device Lot Number: 134240
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 11/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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