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

Model Number 102208-905

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing investigation and the results will be provided in the supplemental report.

Event Description

On march 7, 2024, senseonics was made aware of an incident where the patient complained of receiving a low glucose alert even though there was no actual hypoglycemia event.The patient reported that blood glucose (bg) value on (b)(6) 2024 at 10 am was 157 mg/dl where as sensor glucose (sg) value was 48 mg/dl.The system asserted a low glucose alert as the value went below the low glucose alert threshold which was set at 65 mg/dl.The patient had no symptoms and no actions were needed to be taken.

Manufacturer Narrative

The initial investigation was performed on customer synced glucose data on data management system (dms), which is a cloud platform for eversense systems.Based on initial investigation analysis, the sensor glucose (sg) value on (b)(6) 2024 at 10:02 am was 45 mg/dl and blood glucose (sg) value was not entered into the system.The customer did not seek any help as it was not a true hypoglycemia event.An overall review of the system performance did not reveal any malfunction.However, it revealed symptoms consistent with situations where estimated values provided by the app (sg values) were entered as calibrations rather than true bg values.The customer confirmed that in fact he calibrated 2 or 3 times using the app values.Customer was advised to not enter anything other than a true bg meter value as it 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 updated to 19 april 2024.G3.Date received by manufacturer updated to 19 april 2024.H3.Device evaulated 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: 19048166
• MDR Text Key: 339435853
• Report Number: 3009862700-2024-00597
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 102208-905
• Device Catalogue Number: FG-3500-05-001
• Device Lot Number: 139176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2023
• 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