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

Model Number 102208-705

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Based on the investigation, the system displayed temporary mismatch between the sensor readings and fingerstick calibration entry on (b)(6).Per the glucose plot following the event, the transient noise later subsided and thereafter the system displayed good agreement between the sensor readings and fingerstick calibration entries.

Event Description

On february 4, 2021, senseonics was made aware of an incident where patient experienced a hypoglycemia event on (b)(6) 2021.Sensor reading was 118 mg/dl and the blood glucose measurement was 46 mg/dl.Low glucose alert was set at 80 mg/dl and since the sensor value did not go below the alert level, low glucose alert was not asserted.Patient managed the incident on his own and did not require any medical attention.

• 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: 18965297
• MDR Text Key: 338431824
• Report Number: 3009862700-2024-00179
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/11/2020
• Device Model Number: 102208-705
• Device Catalogue Number: FG-3400-05-001
• Device Lot Number: 116392
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2019
• 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