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

Model Number 102208-600

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem Hypoglycemia (1912)

Event Date 01/16/2024

Event Type  Injury  

Manufacturer Narrative

This mdr is a result of retrospective review of complaints.The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On january 16, 2024, senseonics was made aware of an adverse event where the user received several low glucose alerts in his sleep but did not hear the alerts.

Manufacturer Narrative

Customer reported receiving low glucose alerts on (b)(6) 2024 between 6:07 am to 8:37 am, with sg = 57mg/dl at 6:07 am and bg is not entered since the customer was asleep.Upon review of dms data, it was observed that the user received low glucose alerts on 6:07 am et when the sg was at 57 mg/dl, and the user kept receiving these alerts every 10 minutes until 8:37 am.The customer confirmed that he had no symptoms related to hypoglycemia during the entire period, his only concern was that he didn't hear the alerts.In associated case (b)(4) (complaintrec-45209), the user stated that they are being alerted when the application is in the background, but they don't receive alerts when the application is in the foreground.Customer care attempted to reach out to the customer to provide an escalation response, however, the customer has been unresponsive.Sensor accuracy was assessed 2 weeks prior to the reported event, and the system was working within expectation with mard = 7.3.The customer is currently using the system and the overall system performance is still within expectations.The sensor is functioning as intended with mard is well within normal bounds.B4.Date of this report (b)(6) 2024.G3.Date received by the manufacturer? 29 feb 2024.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: 18764437
• MDR Text Key: 336050011
• Report Number: 3009862700-2024-00073
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/16/2024
• Device Model Number: 102208-600
• Device Lot Number: 135515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Male