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

Model Number 102208-853

Device Problems Connection Problem (2900); Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 10/25/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Sensor was inserted on (b)(6) 2021.The information in data management system (dms) has become available starting from (b)(6) 2021 and has lot of gaps in there due to transmitter battery completely being depleted.Moreover, user did not provide any specific date, time and glucose values of the incident.User did not provide any further information.As a result, no data management system (dms) investigation was possible for this complaint and the complaint could not be confirmed.The issue with sensor linkage/sensor connection was addressed in a separate case where user was guided through troubleshooting steps to successfully link the sensor.

Event Description

On (b)(6) 2021, senseonics was made aware of an incident where patient reported that she often gets hypolgycaemic around 3 am to 4 am almost every night since two weeks.She gets strange ideas, and it takes a long time before she realizes she is having a hypo.Patient did not provide any specific examples.The glucose values will be usually 2.3 mmol/l to 2.6 mmol/l.She said she did not receive any alerts because sensor was not yet connected at that time.

• 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: 19009465
• MDR Text Key: 338981232
• Report Number: 3009862700-2024-00263
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023070
• UDI-Public: 817491023070
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 03/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/16/2021
• Device Model Number: 102208-853
• Device Catalogue Number: FG-3400-53-101
• Device Lot Number: 121769
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2020
• 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