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

Model Number 102208-600

Device Problem Insufficient Information (3190)

Patient Problems Hypoxia (1918); Respiratory Failure (2484)

Event Date 02/15/2023

Event Type  Injury  

Manufacturer Narrative

User experienced acute respiratory failure with hypoxia and was hospitalized.The adverse event was not related to the use of the eversense continuous glucose monitoring system.No further investigation was found necessary.

Event Description

On february 23, 2023, senseonics was made aware of an adverse event where the user experienced acute respiratory failure with hypoxia.

• 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
• Manufacturer Contact: tina kim ; 20451 seneca meadows parkway; germantown
• MDR Report Key: 16616464
• MDR Text Key: 312008760
• Report Number: 3009862700-2023-00057
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• 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: 129858
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 76 YR
• Patient Sex: Female