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

Model Number 102208-600

Device Problem Calibration Problem (2890)

Patient Problem Hypoglycemia (1912)

Event Date 02/28/2023

Event Type  Injury  

Manufacturer Narrative

No medication was given by the paramedics.The hypoglycemia was resolved by drinking juice and food intake.A sensor replacement was authorized due to sensor inaccuracy.The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On february 28, 2023, senseonics was made aware of an adverse event where the user became unconscious soon after she started feeling hypoglycemia symptoms.Her coworkers had to call 911.

Manufacturer Narrative

The event reported on (b)(6) 2023 could not be confirmed as neither the bg nor sg reported by the user could be found on the data management system.However, it was observed that the sensor performance deviated from normal behavior around the same period, which was likely affected by the user's having infection around the sensor insertion site.The onset of the infection was reported to be around (b)(6) 2023.A sensor replacement was authorized as part of complaint (b)(4) for sensor inaccuracy issue, and a further investigation will be performed once the sensor is returned to senseonics.Investigation results will be documented as part of complaint (b)(4).At the time of event, the user passed out due to hypoglycemia and was helped by her coworkers who called 911.The user was able to recover by drinking juice and eating food.The user was inserted with a new sensor on (b)(6) 2023, which is currently performing within expectations.No further resolution was found necessary for this complaint.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 213.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 20875 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: tina kim ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 16645939
• MDR Text Key: 312346455
• Report Number: 3009862700-2023-00078
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 817491022912
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• 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: 02/28/2023
• 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): Hospitalization
• Patient Age: 27 YR
• Patient Sex: Female