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

Model Number 102208-750

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 12/06/2021

Event Type  Injury  

Event Description

On december 8, 2021, senseonics was made aware of a false hyperglycemia event due to alleged sensor inaccuracies on 06-december-2021 at 11:19 pm.The blood glucose (bg) value was 114 mg/dl where as sensor glucose (sg) value was 340 mg/dl.User received high glucose alerts even though bg was in normal range.The high alert threshold was set at 180 mg/dl.User had no symptoms at the time of incident and did not require any medical attention.User mentioned that he generally takes insulin whenever there is hyperglycemia.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Transmitter was the initial suspected device.However, it was not requested to be returned for evaluation as it was still being used by the user.The complaint of resulting from an inaccuracy was investigated and confirmed based on user's data in data management system (dms).A rate of change of the performance indicators revealed that the cause of the reported inaccuracy is noise in the signal 'on' channels, affecting the glucose modulation.Due to sensor performance issues, a return material authorization (rma) was issued for sensor to investigate the issue further.The sensor was tested in-house, and the review of qc did not reveal any malfunction of the sensor.In some instances, the failure mode (sensor performance) that presents itself in the body cannot be reproduced in the lab upon returned product analysis mainly as the test conditions do not replicate the exact conditions in-vivo at the time of failure, and the explant and subsequent decontamination of the product might also alter the state of the sensor.Based on historical data of similar incidents, the shift (i.E.Sudden decline) in sensor chemical performance that occurs within the initial weeks of sensor insertion could potentially be attributed to insufficient hydration of chemical component of the sensor, for which senseonics is continuing to investigate to learn more about the failure mode and resolution.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 18754610
• MDR Text Key: 335934550
• Report Number: 3009862700-2024-00300
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2022
• Device Model Number: 102208-750
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 122398
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other