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

Model Number 102208-850

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 09/25/2022

Event Type  Injury  

Event Description

On september 26, 2022, senseonics was made aware of a false hypoglycemia incident where patient complained of inaccurate sensor readings.The incident happened on (b)(6) 2022 at around 3:00 pm.Patient reported that bg was 6.8 mmol/l where as sg reading was 4.2 mmol/l the eversense cgm system alerted low glucose even through bg was normal.User was not symptomatic and did not require any treatment.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.The transmitter was not requested to be returned for evaluation as the preliminary analysis suggested the issue was temporary.The investigation analysis was based on the user's in vivo sensor data synced by the user on the data management system (dms), which is the data cloud platform for eversense systems.The reported fingerstick or the blood glucose (bg) value of 6.8 mmol/l around 3 pm cet on (b)(6) 2022, was not found in the dms, as it was likely not entered in the system.The reported sensor glucose (sg) reading of 4.2 mmol/l could not be confirmed as dms showed the sg value was 5.7 mmol/l at the time of event, which was within 20% of the fingerstick measurement (considered acceptable).The fingerstick measurements before and after the event displayed good agreement with the sensor readings.The overall system performance was reviewed, and it was performing within acceptable parameters.Currently, the sensor is in use and the system is displaying good agreement between the sensor readings and fingerstick measurements.No additional 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: 19009471
• MDR Text Key: 338981148
• Report Number: 3009862700-2024-00370
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491023094
• UDI-Public: 817491023094
• 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: 03/31/2024

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: 09/28/2022
• Device Model Number: 102208-850
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 126886
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2021
• 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