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

Model Number 102208-919

Device Problem Calibration Problem (2890)

Patient Problem Hypoglycemia (1912)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The investigation analysis 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 reported event could not be confirmed as there was no blood glucose (bg) or the calibration entry of 2.8 mmol/l at the time of event.The system was displaying 6 mmol/l at the time of event.The investigation analysis showed that sensor was still settling at the time of incident as it was inserted on (b)(6) 2023.Typically, in the first several days after the insertion, the wound healing response to the insertion site can lead to either a hinderance of the sensor's access to the glucose in the interstitial fluid or an initial depression of the optical signal, or both.This incident happened during initial settling period and once the sensor stabilized after insertion, the system started to perform within expectations.The current sensor performance is within expectations.No further investigation was found necessary for this complaint.

Event Description

Senseonics was made aware of a hypoglycemia event where the patient was not alerted by the eversense cgm system likely due to sensor inaccuracies.The patient reported that the blood glucose (bg) value was 2.8 mmol/l and the sensor glucose (sg) value was 6.09 mmol/l.The patient felt symptoms of hypo, but was able to self resolved by taking carbs.The patient did not require any medical attention.

• 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: 18117157
• MDR Text Key: 327886108
• Report Number: 3009862700-2023-00254
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• 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: 11/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/13/2023
• Device Model Number: 102208-919
• Device Catalogue Number: FG-3500-09-101
• Device Lot Number: 132075
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• 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