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

Model Number 102208-600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Concussion (2192); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/22/2022

Event Type  Injury  

Event Description

On (b)(6) 2023, senseonics was made aware of an adverse event where the user fell due to a synocopal episode which resulted in a concussion and other intracerebral and spinal injuries.The injuries resulted in the user being hospitalized.The issue was not related to eversense continuous glucose monitor system.

Manufacturer Narrative

The user experienced a syncopal episode which caused the user to be hospitalized with a concussion, intracerebral hemorrhage, subdural hemorrhage and paraspinal lipoma.The syncopal episode is thought to be caused by low blood pressure and was not related to the users blood sugar or the eversense continuous glucose monitor system.No further investigation was found necessary.

Manufacturer Narrative

The user was hospitalized for the injuries caused by the fall due to the syncopal episode.The syncopal episode was thought to be caused by low blood pressure and was not related to the user's blood sugar or the eversense continuous glucose monitor system.No further investigation was found necessary as this was a non-device related incident.

Event Description

On 11 january 2023, senseonics was made aware of an adverse event where the user fell due to a syncopal episode which resulted in a concussion and other intracerebral and spinal injuries.The injuries resulted in the user being hospitalized.This incident was not related to eversense continuous glucose monitor system.

• 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: 16358555
• MDR Text Key: 309366829
• Report Number: 3009862700-2023-00032
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/27/2023
• Device Model Number: 102208-600
• Device Catalogue Number: N/A
• Device Lot Number: 131102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2022
• 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: 59 YR
• Patient Sex: Male