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

Model Number 102208-600

Device Problem Imprecision (1307)

Patient Problems Hyperglycemia (1905); Urinary Tract Infection (2120)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On february 26, 2024, senseonics was made aware of an adverse event where the user went to the emergency room due to a hyperglycemia event.The system did not assert a high glucose alert at the time of event.The user reported that he had been taking jardiance (empagliflozin) prescribed by his hcp since (b)(6) 2024, which caused several side effects, and on the 16th of february the user couldn't go to work due to the side effects.He stopped taking the medication on that day.On (b)(6) 2024, the user had to go to the er where he was diagnosed with a urinary tract infection and hyperglycemia.

Manufacturer Narrative

The user reported a hospitalization event where the user was admitted to the er and diagnosed with hyperglycemia.The dms data confirmed the user did not receive a high glucose alert at the event because the sg values never went about the high alert setting.From an associated complaint of sensor inaccuracy, it was observed that the user's past calibration entries were consistent with situations where estimated values provided by the app are used instead of the user's true bg values.Entering anything other than a true bg value can disrupt the calibration and lead to significant deviations in the sensor readings displayed, and this can have an impact for several days after resuming normal calibration.The user was advised to not enter anything other than a true bg meter value, from a finger stick, when calibrating.The user received treatment at the hospital.No further investigation was found necessary for this complaint.B4.Date of this report updated to 12 april 2024.G3.Date received by manufacturer updated to 11 april 2024.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 4109.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 67.

• 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: 18989856
• MDR Text Key: 338742898
• Report Number: 3009862700-2024-00578
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/16/2024
• Device Model Number: 102208-600
• Device Lot Number: 135515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• 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): Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male