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

Model Number 102208-704

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); Muscle Weakness (1967); Blurred Vision (2137)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Based on the initial analysis for the reported hypoglycemia event/ sensor inaccuracies, it was observed that the optical channel was trying to slowly recover after insertion on 5th of (b)(6) 2021, but it was taking longer than usual to recover.And since the measurement of sensor performance (msp) was at 0.102 (at the time), there was a high possibility that the msp may not recover in time before day 21 (meaning go above the failure threshold of 0.35) and therefore, the system may end up asserting a sensor replacement on day 21.Patient was advised to schedule for an early sensor removal.

Event Description

On february 17, 2021, senseonics was made aware of an incident where patient experienced hypoglycemia event.Patient experienced symptoms such as poor vision and weakness.Sensor glucose (sg) was 156 mg/dl where the blood glucose meter (bgm) showed 46 mg/dl.Patient said she did not receive any alert.Patient was able to manage the hypoglycemia event on her own by ingesting glucose.She did not require any medical attention/intervention.

• 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: 18976385
• MDR Text Key: 338551890
• Report Number: 3009862700-2024-00181
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2021
• Device Model Number: 102208-704
• Device Catalogue Number: FG-3400-04-001
• Device Lot Number: 120314
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• 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