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

Model Number 102208-600

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); Shaking/Tremors (2515)

Event Date 02/07/2023

Event Type  Injury  

Event Description

On february 09, 2023, senseonics was made aware of an adverse event where the user experienced a hypoglycemia event on (b)(6) 2023, with no alert asserted by the system due to a sensor inaccuracy.

Manufacturer Narrative

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

Manufacturer Narrative

Based on the investigation analysis, on february 7, 2023, the calibration entry of 66 mg/dl closely matched the sensor reading of 67 mg/dl at that time.The system displayed good agreement between the sensor readings and calibration entries during the time of the event.There were no hypoglycemia alerts asserted at the time because the sensor readings did not cross the low alert threshold of 60 mg/dl set by the user.The overall performance of the sensor, before and after the event, was within expectations.Per case notes, the user did not seek medical treatment and was able to resolve it by taking sugar with assistance from her brother.The sensor is currently in use and the system is displaying good agreement between the sensor readings and calibration entries.No further resolution was found necessary for this complaint.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 67, 4315.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 16526835
• MDR Text Key: 311124635
• Report Number: 3009862700-2023-00073
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 129745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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
• Patient Age: 41 YR
• Patient Sex: Female