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

Model Number 102208-905

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 11/13/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer is currently performing evaluation and the results will be provided in the supplemental report.

Event Description

Senseonics was made aware of a false hypoglycemia event and the patient complained of inaccurate glucose readings.The patient reported that the sensor glucose (sg) reading was 49 mg/dl and the system asserted a low glucose alert.However, the patient did not have any low glucose symptoms.The patient did not check the blood glucose value and hence did not provide that information.The patient did not have to take any actions or seek any medical attention.

Manufacturer Narrative

The investigation was performed on the user synced glucose data on data management system (dms), which is an eversense cloud platform.Based on the investigation analysis, the sensor glucose (sg) value was 52 mg/dl at 11:18 am and 57 mg/d at 11:23 am.The customer did not enter blood glucose (bg) values at these times and as a result, the mismatches or discrepancy cannot be confirmed.The system asserted low glucose alerts at the time of incident since it went below the alert threshold.A review of the available glucose data on dms revealed symptoms consistent with situations where estimated values provided by the app (sg values) were entered as calibrations rather than true fingerstick bg entry.Customer was advised to not enter anything other than a true bg meter value, from a finger stick, when calibrating.Entering estimated values or values from the eversense cgm or another cgm, can disrupt the calibration and lead to significant deviations in the sensor readings.The customer continued to use the system until the sensor reached the end of life.No further investigation was found necessary for this complaint.B4.Date of this report 26 april 2024.G3.Date received by the manufacturer? 29 dec 2023.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: 18314253
• MDR Text Key: 330308999
• Report Number: 3009862700-2023-00823
• 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,Followup
• Report Date: 04/26/2024

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: 01/09/2024
• Device Model Number: 102208-905
• Device Catalogue Number: FG-3500-05-001
• Device Lot Number: 135468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/29/2023
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• 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