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

Model Number 102208-750

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Ased on the investigation of the event on (b)(6) 2021, there was inherent lag in the sensing technology of the sensor and that the sensor glucose eventually caught up to the calibration (capillary) entry after 3-4 sensor readings.The investigation of the event on (b)(6) 2021 showed that the system was not within the 20/20 error target of the system.But this is not due to a system failure, and it was within the 30/30 error bounds of the cgm system, this occasional occurrence is still consistent with normal system operation.The system did not assert the hypo alert as the sensor readings did not cross the low glucose alert threshold at the time of the event.

Event Description

On (b)(6) 2021, senseonics was made aware of a hypoglycemia event where user complained of not receiving low glucose alerts.The event occurred on (b)(6) 2021 at 02:23 am.The blood glucose (bg) value was 51 mg/dl where as sensor glucose (sg) value was 84 mg/dl.User was symptomatic (cravings, sweat, racing heart, dizziness).User did not receive alerts because the low alert threshold was set at 60 mg/dl and sg value did not cross it.User did not require any medical treatment and was able to self treat.

• 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: 19009472
• MDR Text Key: 338981081
• Report Number: 3009862700-2024-00299
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491023087
• UDI-Public: 817491023087
• 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: 03/31/2024

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: 02/05/2022
• Device Model Number: 102208-750
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 122491
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2021
• 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 Outcome(s): Other