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

Model Number 102208-500

Device Problem Calibration Problem (2890)

Patient Problem Hypoglycemia (1912)

Event Date 05/06/2021

Event Type  Injury  

Manufacturer Narrative

Upon analysis of the system on the 6th of may 2021, it was observed that the system had first asserted low glucose alert at 7:36 pm est, which is approximately 1 hour before the customer support call was made.During the call the user mentioned the system was in sensor suspend phase and did not allow the user to enter calibration for 6 hours, which is per design.The user expressed hypoglycemic symptoms while on the call and at this time the system was already in sensor suspend phase and there were no sensor glucose readings displayed on the app.The system had started to alert the user of the hypo event around 7:36 pm est on (b)(6) 2021, approximately an hour before the user called to report the sensor suspend alert.Per dms alert history page, the low glucose alerts were asserted and displayed on the app until 8:11 pm est just before the sensor suspend alert at 8:16 pm est, at which point, the system stopped displaying glucose related alerts as glucose was blinded.This is per design.There is no further investigation needed at this time as the system did alert the user of the hypo event.

Event Description

On may 06th 2021, senseonics was made aware of an adverse event where user expressed hypoglycemic symptoms while on the call and at this time the system was already in sensor suspend phase and there were no sensor glucose readings displayed on the app.User did not provide date and time of the event.

• 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: 11943511
• MDR Text Key: 254487297
• Report Number: 3009862700-2021-00078
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 817491021441
• 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
• Report Date: 05/06/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2021
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 117558
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/14/2020
• 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 Age: 83 YR