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

Model Number 102204-005

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 03/16/2019

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.The investigation of the data available in the data management system showed that the eversense sensor glucose value was recorded at 237 mg/dl at 11:00pm the day of the event.At 12:00 am the eversense sensor glucose value was at 203 mg/dl.The user reported taking insulin at 11:00pm and tested his blood glucose via a fingerstick and reported the value was 20 mg/dl around 12 am.The user did not enter the blood glucose value as a manual entry nor as a calibration in the system.The eversense sensor value never went below 113mg/dl until around 4 am and as a result the low glucose alert was not triggered.The cgm also has the lowest glucose operational limit of 40 mg/dl.A potential cause of the discrepancy with the reported blood glucose value is likely due to transient sensor inaccuracy caused by sensor lag, at that range of time (12:05am-12:30am), when the glucose was dropping fast at > 2mg/dl/min.However, this could not be confirmed based on the available recorded data.The blood glucose entries entered by the user during the week prior to the reported incident, matched closely with the cgm value.

Event Description

On march 22, 2023, senseonics was made aware of an instance wherein a patient using eversense cgm system went through a hypoglycemia event.The patient reported the eversense cgm system reported a high glucose reading which resulted in him treating himself with insulin, which lowered high actual blood glucose resulting in the hypoglycemia event.The patient also reported that he verified his glucose levels using a blood glucose meter prior to treating himself with insulin.The patient was subsequently taken to the hospital to receive care from a physician.

• 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: 18415800
• MDR Text Key: 331577523
• Report Number: 3009862700-2023-00361
• Device Sequence Number: 1
• Product Code: QCD
• 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
• Report Date: 12/28/2023

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: 08/22/2019
• Device Model Number: 102204-005
• Device Lot Number: 109181
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2018
• 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