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

Model Number 102208-995

Device Problem Imprecision (1307)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 11/06/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer is currently performing evaluation and the results will be provided in the supplemental report.

Event Description

Senseonics was made aware of a serious adverse event where the patient was hospitalized due to hyperglycemia and ketoacidosis.According to the information that was provided by the patient.The sensor glucose was showing 136 mg/dl at the time of incident.The blood glucose (bg) value measured at the emergency room was 560 mg/dl.The patient did not receive a high glucose alert because the sg value did not cross the high glucose alert threshold which was set at 220 mg/dl.The patient was treated with insulin drops, potassium and was hydrated.The patient is currently doing well.

Manufacturer Narrative

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 sensor glucose (sg) on 06 november 2023 at 1:02 am was 131 mg/dl and blood glucose (bg) fingerstick entry was 131 mg/dl at 1:02 am.The system did not assert high glucose alert at the time of event because the sg value never crossed the high glucose alert setting of 220 mg/dl.A review of the available glucose data on dms revealed symptoms consistent with situations where estimated values provided by the app (sg values) were entered as calibrations rather than true fingerstick bg entry.Customer acknowledged that they were entering values from eversense cgm.Customer was advised to not enter anything other than a true bg meter value, from a finger stick, when calibrating.Entering estimated values or values from the eversense cgm or another cgm, can disrupt the calibration and lead to significant deviations in the sensor readings.B4.Date of this report update to 19 march 2024.G3.Date received by manufacturer updated to 21 december 2023.H3.Device manufacturer by manufacturer? yes.

• 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: 18278892
• MDR Text Key: 329869121
• Report Number: 3009862700-2023-00816
• 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,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/08/2023
• Device Model Number: 102208-995
• Device Catalogue Number: FG-3500-05-001
• Device Lot Number: 130325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• 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): Hospitalization