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

Model Number 101967-950

Device Problem Communication or Transmission Problem (2896)

Patient Problem Hyperglycemia (1905)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.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 system asserted an out of range high glucose alert at 05:28 am (time of incident).There was no sensor readings displayed because of this alert.The alert history also showed multiple high-glucose alerts issued to the user at 2: 03am and 5: 03am, before the reported event at 5:28am.The customer had to call an ambulance but refused to go to the hospital.She received an infusion and was feeling fine.The system performed as intended by asserting high glucose alert at the time of incident.Overall, the system was performing as intended and the customer entered calibrations fit sensor glucose (sg) trends well with the exception of some instances where calibrations were too close or matched exactly with sg value.This behavior suggests that customer sometimes enters sg values itself for calibration instead of entering true fingerstick blood glucose (bg) values.The customer was recommended to enter true finger stick bg values for calibration as anything other than that could result in significant deviations.No further investigation was found necessary for this complaint.

Event Description

Senseonics was made aware of an incident where the customer experienced hyperglycemia on (b)(6) 2023.The customer reported that the blood glucose (bg) value was above 400 mg/dl, but the eversense cgm system did not show any glucose values or provided alert.Customer called an ambulance and received an infusion, but did not know which medication.The customer did not go to the hospital and is currently doing fine.

• 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: 18117044
• MDR Text Key: 327885609
• Report Number: 3009862700-2023-00226
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 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: 06/08/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: 129966
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2023
• 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): Other