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

Model Number 101967-931

Device Problem Calibration Problem (2890)

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

Event Date 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.In associated e3 case # (b)(4).After the user performed a transmitter reset, the system went back to initialization phase.The user performed 2 calibrations which afterwards the system went back again to 4 calibrations.Per the c3 case notes # (b)(4).The calibration problems persisted after relinking the sensor and replacing the transmitter i.E., after the second calibration the user cannot see glucose data and is back to 4 calibrations.A sensor replacement was approved due to system performance.No problem was found with the returned sensor's chemical performance.Transmitter 204305, returned under complaint (b)(4).Showed no issues during in-house testing.Log file analysis showed that there was bad calibration.This is due to in-vivo reference na values being significantly lower than the in-vitro reference zbleed (characterized from qc) values.This results in negative mop/nmop values.Since there are conditions in the algorithm that mop/nmop values need to be >0, the customer got bad calibration parameters in-vivo, and per system design, the glucose will be blinded when this occurs.

Event Description

On(b)(6)2023 senseonics was made aware of an incident where user was unable to complete a diagnostic upload and sensor replacement was approved due to system performance.

• 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: 18909831
• MDR Text Key: 337743891
• Report Number: 3009862700-2024-00541
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: IS
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/12/2023
• Device Model Number: 101967-931
• Device Catalogue Number: FG-4500-31-302
• Device Lot Number: WP09045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• 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