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

Model Number 102208-905

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 12/08/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2023, senseonics was made aware of a serious adverse event where the patient lost consciousness because of hypoglycemia.The incident happened on 08 december 2023 at around 6 pm.The customer did not measure the blood glucose value due to being unconscious but mentioned that no alerts were received from the cgm system.A review of the glucose data showed that the sensor glucose (sg) value at 5:59 pm was 134 mg/dl and at 06:04 pm was 130 mg/dl.The customer self resolved the event by eating sugar.

Manufacturer Narrative

The initial investigation was performed on the user synced glucose data on data management system (dms), which is a cloud platform for eversense systems.Based on the investigation analysis, the sensor glucose (sg) value on (b)(6) 2023 at 5:59 pm was 134 mg/dl and at 6:04 pm was 130 mg/dl.The blood glucose (bg) value was not entered into the system.The system did not assert a low glucose alert at the time of event because the sg value never went below the low glucose alert setting of 70 mg/dl.A further review of the glucose data on dms suggested that the patient was performing calibrations by entering the estimated values provided by the app (sensor glucose readings) instead of entering true finger stick bg readings.The patient was advised to not enter anything other than a true bg meter value, while calibrating.Entering values or value from the eversense cgm or another cgm, can disrupt the calibration and lead to significant deviations in the sensor readings.No further investigation was found necessary for this complaint.B4.Date of this report 29 april 2024.G3.Date received by the manufacturer? 19 jan 2024.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 19.

• 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: 18480525
• MDR Text Key: 332490644
• Report Number: 3009862700-2023-01033
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023407
• UDI-Public: 817491023407
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2023
• Device Model Number: 102208-905
• Device Catalogue Number: FG-3500-05-001
• Device Lot Number: 133445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• 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