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 12/17/2021

Event Type  Injury  

Event Description

Senseonics was made aware of a false hypoglycemia event due to alleged sensor inaccuracies on 17-december-2021 at around 8:00 am.The reported blood glucose (bg) value was 92 mg/dl and sensor glucose (sg) value was 44 md/dl.User received low glucose alerts even though bg was in normal range and user had no symptoms at the time of incident.User did not require any medical attention.

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 on user's data in data management system (dms), the hypo alert was asserted before the fingerstick measurement was performed and following the calibration entry, the system demonstrated the inherent lag in the sensing technology of the sensor and that the sensor glucose eventually caught up to the calibration (capillary) entry within 3-4 sensor readings.As the sensor performance started to improve after insertion, so did the accuracy of the sensor.Following the reported event, the system is displaying good agreement between the sensor readings and fingerstick measurements.

• 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: 19008682
• MDR Text Key: 338980296
• Report Number: 3009862700-2024-00306
• 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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102208-750
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 122398
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2022
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other