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

Model Number 102208-905

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing investigation and results will be provided in a supplemental report.

Event Description

On february 21, 2024, senseonics was made aware of a hyperglycemia event that happened on (b)(6) 2024 at around 12:30 pm.The customer reported that the blood glucose (bg) value was 372 mg/dl where as the eversense cgm system showed a sensor glucose (sg) reading of 211 mg/dl.The customer did not receive a high glucose alert since sg reading did not cross above the high glucose alert threshold which was set at 260 mg/dl.The customer did not seek any medical attention and was able to self resolve.

• 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: 18956129
• MDR Text Key: 338307733
• Report Number: 3009862700-2024-00095
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023407
• UDI-Public: 817491023407
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2023
• Device Model Number: 102208-905
• Device Catalogue Number: FG-3500-05-001
• Device Lot Number: 134194
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2022
• 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