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

Model Number 102208-904

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 06/12/2023

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where the customer experienced a hyperglycemia event on (b)(6) 2023 at 9:58 am.The customer reported that sensor glucose (sg) was 218 mg/dl where as the measured blood glucose (bg) value was 376 mg/dl.The customer complained of not being alerted by eversense cgm system.The customer administered insulin and did not seek any medical attention.

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.A review of the glucose data showed a blood glucose (bg) value of 276 mg/dl at 06:20 am which was marked as suspicious.At that time the sensor glucose (sg) value was 167 mg/dl.The system prompted for additional calibrations.The additional calibrations that were entered at 07:38 am (bg=282 mg/dl) and at 09:58 am (bg=218 mg/dl) were also marked as suspicious as the respective sg values were 148 mg/dl and 160 mg/dl.Because of the consecutive suspicious calibrations, the system asserted sensor suspend alert, where the system blinds the glucose readings for 6 hours.This allows the algorithm sometime to recalibrate and restart in initialization phase.Post-reinitialization, the sensor readings closely matched calibration entries and the customer had no further measurement deviations.The system worked as expected thereafter and the customer is currently using the system with up to date information.The raw in-vivo sensor data from insertion until the event did not reveal any abnormal behavior, and sensor performance metrics did not indicate any performance malfunction.The inaccuracy that was observed at the time of incident may potentially be related to the in-vivo state of sensor hydrogel.Since the system functionality returned to the normal behavior post reinitialization, 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: 18117349
• MDR Text Key: 327880169
• Report Number: 3009862700-2023-00273
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 11/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/22/2023
• Device Model Number: 102208-904
• Device Catalogue Number: FG-3500-04-001
• Device Lot Number: 130278
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• 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