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

Model Number 102208-600

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 11/25/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, 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 analysis, the first reported event at 5:50 am est on november 25, 2022, demonstrated the inherent lag in the sensing technology of the system and that the sensor glucose eventually caught up to the calibration (capillary) entry after 3-4 sensor readings.Per the analysis of the second reported event at 8:07 pm est on november 25, 2022, following the calibration entry at 8:07 pm est, the system adjusted the glucose calculation in response to the calibration entry.The system reading adjusted to 100 mg/dl at 8:09 pm est.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 glucose readings in comparison with incoming fingerstick measurements.The analysis of the third event at 7:46 pm est on november 26, 2022, also demonstrated the inherent lag in the sensing technology of the system and that the sensor glucose eventually caught up to the calibration (capillary) entry after 3-4 sensor readings.The reported events happened during the initial few days after sensor insertion.During the initial settling period after sensor insertion, there could be chances of temporary mismatch, which would eventually normalize as the sensor stabilizes.In this case, once the sensor recovered after insertion, the system began performing within expectations and there was better accuracy between the sensor readings and fingerstick measurements.No further investigation was found necessary for this complaint.User did not need to take any treatment actions as the blood glucose level was not the hypoglycemia range.The sensor had stabilized since the event and been performing well within expectations.H3.Device evaluated by manufacturer?: yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• 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: 16062495
• MDR Text Key: 306279728
• Report Number: 3009862700-2022-00197
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 128877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2022
• 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: 56 YR
• Patient Sex: Female