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

Model Number 102208-500

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 11/25/2021

Event Type  Injury  

Event Description

On (b)(6) 2021,senseonics was made aware of an incident where user experienced false hypoglycemia due to inaccuracies in sensor readings.

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Manufacturer Narrative

Based on the investigation, there was discrepancy with time of the reported event; the user indicated the event between 2-3am however the logs indicate the event at 6am.Upon review of the data between 2 am est and 7 am est, on (b)(6), it was observed there was 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.Once the sensor performance recovered as the sensor use moved away from the insertion date, the system displayed better accuracy and there was good agreement between the sensor readings and fingerstick measurements following the event.User did not require medical intervention or treated herself as she wasn't symptomatic.As per dms, user is currently using the system with up to date information.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 13085568
• MDR Text Key: 282780399
• Report Number: 3009862700-2021-00154
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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,Followup
• Report Date: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/12/2022
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 123501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2021
• 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 Age: 70 YR
• Patient Sex: Female