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 11/14/2023

Event Type  malfunction  

Event Description

On november 20, 2023, senseonics was made aware of an incident where the patient complained of discrepancy between eversense values and blood glucose (bg) meter values.The patient provided the below examples.1.(b)(6) 2023 22:15 48 mg/dl 140 mg/dl; 2.(b)(6) 2023 21:00 47 mg/dl 66 mg/dl; 3.(b)(6) 2023 21:39 66 mg/dl 134 mg/dl; 4.(b)(6) 2023 08:08 180 mg/dl 213 mg/dl.A review of the glucose data on the data management system (dms) suggested a deviation in the system performance and hence a sensor replacement was approved.There were no adverse events associated with this incident and no medical attention was required.The patient will have the sensor removed.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Based on the initial analysis, the sensor deviated from normal behavior.An rma was issued for further investigation.The investigation analysis on the returned sensor (b)(6) was inconclusive due to a large amount of hydrogel missing over the optics of the sensor.The hydrogel damage is likely to have occurred during the removal procedure.No further investigation is possible for this complaint.As part of resolution, the rma was authorized to offer the user a sensor replacement.

• 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: 18785611
• MDR Text Key: 337425991
• Report Number: 3009862700-2024-00538
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/22/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• 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