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

Model Number 101967-950

Device Problem Failure to Sense (1559)

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

Event Date 10/28/2022

Event Type  malfunction  

Event Description

Senseonics was made aware of an incident where the user received an early sensor replacement alert resulting in early sensor removal.The user received the alert on (b)(6) 2022, on day 03 of sensor life.No adverse events were associated with this complaint.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The sensor was investigated.Review of in-vivo data in dms shows that a led disconnect error was triggered on (b)(6) 2022.In-vitro qc test did not find any performance issue with the sensor.However, sensor manager software measurements test of the sensor showed that the led flag for sensor (b)(6) cleared at field current threshold higher than 412 adc counts which is the root cause of this issue.No further investigation was possible for this complaint.As part of resolution, the customer was offered a sensor replacement.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 19009070
• MDR Text Key: 339246952
• Report Number: 3009862700-2024-00387
• 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
• Type of Report: Initial
• Report Date: 03/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP08962
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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