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

Model Number 102208-750

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2021

Event Type  Injury  

Event Description

Senseonics was made aware of a false hypoglycemia event due to alleged sensor inaccuracies on (b)(6) 2021 at around 10:25 pm.The blood glucose (bg) was 90 mg/dl where as sensor glucose (sg) was 44 mg/dl.User received low glucose alert even though bg was in normal range.User did not have any symptoms and hence did not require any medical attention or self treatment.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The investigation was performed on the user synced glucose data in data management system (dms), which is a cloud platform for eversense systems.Based on the investigation analysis, there are several ways the system would adjust glucose calculations to account for the fingerstick measurement and one such mechanism is calibration entries which are used to better match the incoming fingerstick measurements.The hypo alerts were asserted before the calibration entry and the system adjusted the glucose values based on the calibration entry.Even though the system did assert the hypo alerts, however, upon overall analysis of the sensor diagnostics, there was temporary noise in the optical channel between december 18 to 20 that caused some temporary inaccuracy.The sensor 240546 was explanted on (b)(6) and on the same day, the customer was inserted with a new sensor which is performing well.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 19008677
• MDR Text Key: 338979096
• Report Number: 3009862700-2024-00310
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): N
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/04/2022
• Device Model Number: 102208-750
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 122465
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other