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

Model Number 101967-950

Device Problem Imprecision (1307)

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

Event Date 01/06/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, senseonics was made aware of an incident where the user experienced sensor inaccuracies which led to an early sensor removal.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Based on the initial escalation analysis, the signal channel displayed low modulation which resulted in mismatch between the sensor readings and fingerstick measurements.Per the analysis the root cause could not be confirmed and the rma was issued to further investigate the sensor.Upon receipt of the rma, the sensor (b)(6) was tested in-house, and a qc revealed a loss of chemical performance, which confirms the complaint in-vitro.This pattern is indicative of oxidation of the hydrogel, which is the root cause of the reported inaccuracy.

• 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
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown
• MDR Report Key: 19001449
• MDR Text Key: 338877249
• Report Number: 3009862700-2024-00416
• 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: 03/28/2024

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?: Yes
• Is this a Product Problem Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Date Manufacturer Received: 04/04/2023
• 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
• Patient Outcome(s): Other