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 10/11/2023

Event Type  Injury  

Event Description

Senseonics was made aware of a serious adverse events due to hypoglycemia which happened on (b)(6) 2023 at 10:25 am and 12:10 pm.Both the events led to customer losing consciousness.The sensor glucose (sg) values and the corresponding blood glucose (bg) values at the time of events are as below.1.10:25 am | sg 135 mg/dl - bg 65 mg/dl.2.12:10 pm | sg 110 mg/dl - bg 34 mg/dl.The customer did not seek any medical attention and received assistance from his neighbor who rubbed sugar under the tongue.The customer was recommended to seek advise from the hcp.

Manufacturer Narrative

The manufacturer is currently performing evaluation and the results will be provided in a supplemental report.

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 customer reported blood glucose (bg) values could not be confirmed as the bg values were not entered into the system by the user.At 10:25 am, the sensor glucose (sg) reading was 174 mg/dl and at 12:10 pm, the sg reading was 136 mg/dl.Hence, the customer reported sg values could not be confirmed as well.An overall review of the system performance showed some degradation in the system channel (as sensor was approaching it's end of life) , but mean absolute relative difference (mard) was within specifications.The system eventually retired the sensor on day 167 of sensor life, on (b)(6) 2023.No further investigation was found necessary for this complaint as sensor retirement happened past replacement period.B4.Date of report updated to (b)(6) 2024.G3.Date received by the manufacturer updated to 22 nov 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: 18117187
• MDR Text Key: 327879880
• Report Number: 3009862700-2023-00232
• 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: 01/09/2024

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: 06/28/2023
• Device Model Number: 102208-905
• Device Catalogue Number: FG-3500-05-001
• Device Lot Number: 130325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/11/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2022
• 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 Outcome(s): Other