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

Model Number 102208-750

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); Dizziness (2194); Shaking/Tremors (2515)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Upon review of the case notes, it was observed that the exact date and time for the event was not shared as the user could not remember the date and time of the event.Per the case notes, glucose data was checked between june 28 and july 12 but the event could not be confirmed.The glucose plot between june 28 to july 12 displayed an mean absolute relative difference (mard) of 11.09% which indicates that there was good agreement between the sensor readings and the fingerstick measurement entries.As the event could not be confirmed, no further investigation could be performed at this time.

Event Description

On (b)(6) 2021, senseonics was made aware of an incident where patient experienced a hypoglycemia event.Although patient did not specify the exact date and time of the event, she said the sensor glucose reading was 111 mg/dl and blood glucose was 42 mg/dl and did not receive any low glucose alerts.She had trembling and dizziness at the time of event.

• 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: 19009155
• MDR Text Key: 338981138
• Report Number: 3009862700-2024-00221
• 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: 03/10/2020
• Device Model Number: 102208-750
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 116229
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 03/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2019
• 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