MAUDE Adverse Event Report: SENSEONICS, INCORPORATED EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number 101967-950

Device Problems Premature End-of-Life Indicator (1480); Calibration Problem (2890)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The review of the glucose plot showed that on (b)(6) 2023, there were 4 consecutive suspicious calibrations which led to the sensor suspend phase, where the system blinds the sensor readings for 6 hours which allows the algorithm sometime to recalibrate the glucose calculation and start in initialization phase.After the system was out of the sensor suspend phase, it restarted in initialization phase and displayed better agreement between the sensor readings and fingerstick measurements.On (b)(6) 2023, there were another 4 consecutive suspicious calibrations, resulting in another sensor suspend phase.The system is designed to trigger a sensor replacement alert when two drop-out phases occur 14 days apart within 21 days after the sensor insertion date.It is potential that the calibrations entered by the user were not accurate, resulting in the two drop-out phases.An rma was authorized to offer the user a sensor replacement.

Event Description

On (b)(6) 2023, senseonics was made aware of an incident where the user received an early sensor replacement alert resulting in an early sensor removal.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 19001485
• MDR Text Key: 338991704
• Report Number: 3009862700-2024-00442
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023308
• UDI-Public: 817491023308
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other