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

Model Number 102208-600

Device Problem Imprecision (1307)

Patient Problems Fatigue (1849); Hyperglycemia (1905)

Event Date 10/28/2023

Event Type  Injury  

Event Description

On october 30, 2023, senseonics was made aware of an adverse event where the user went to er for hyperglycemia and having symptoms of fatigue on 24 october 2023.

Manufacturer Narrative

This mdr is a result of retrospective review of complaints.The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Manufacturer Narrative

Customer reported a high glucose event that led to an er visit on (b)(6) 2023 for elevated bg value of 283mg/dl.The customer began experiencing fatigue symptoms on (b)(6) 2023.On that same day, the user entered two calibration entries, one at 3:10 pm (260 mg/dl) and another at 6:43 pm (254 mg/dl).From (b)(6) 2023 2:54 pm through (b)(6) 2023 7:04 pm as there was no sg data available.During that time frame the sensor was frequently not connected to the transmitter resulting in multiple "sensor not detected" alerts, and the user was in the initialization phase due to calibration past due.Upon reviewing the alert history, it was observed that several high glucose alerts were received on 24th, 29th and 30th of october.The user sought medical attention by visiting the emergency room on the 28th october.They subsequently had their metformin dose increased to 100 mg daily on (b)(6) 2023.The primary care physician also initiated ozempic treatment on (b)(6) 2023.The user has been unresponsive and is currently not using the system.No further investigation was possible for this complaint.H3.Device evaluated by manufacturer?no,other h6.Investigation findings updated to 114 h6.Investigation conclusions updated to 4315.

• 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: 18252952
• MDR Text Key: 329550814
• Report Number: 3009862700-2023-00310
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/23/2024
• Device Model Number: 102208-600
• Device Lot Number: 135516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2023
• 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: 40 YR
• Patient Sex: Female