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

Model Number 102208-704

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); Nausea (1970); Dizziness (2194)

Event Date 08/28/2021

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where patient experienced two hypoglycemia events and complained of not high measuring difference values.The sensor glucose (sg) reading was 97 mg/dl and 100 mg/dl where as the blood glucose was 54 mg/dl and 39 mg/dl respectively.No low glucose alerts were asserted as system displayed normal values.Patient did not require any medical attention or intervention and was able to resolve the problem by intaking glucose.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Transmitter was not requested to return for investigation because the eversense xl cgm system is still being used the user.Data management system (dms) investigation was not possible as patient did not want to sync their data.Since there is no data available, the reported event could not be confirmed and there could be no further investigation performed at this time.

• Brand Name: EVERSENSE SENSOR
• 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: 19009181
• MDR Text Key: 338980360
• Report Number: 3009862700-2024-00243
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491023087
• UDI-Public: 817491023087
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 03/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/04/2022
• Device Model Number: 102208-704
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 122465
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 03/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2021
• 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