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

Model Number 102208-853

Device Problem Device Alarm System (1012)

Patient Problems Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2022

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where patient experienced a hypoglycemia on (b)(6) 2021 at around 16:37 hrs.User reported that the blood glucose (bg) was 65 mg/dl where as blood glucose (bg) value was not provided because user did not have access to bg meter at the time of incident.User mentioned that the transmitter vibrated during the incident but did not receive alert on the eversense app as transmitter was not connected.User did not have any symptoms at the time of incident, did not require any medical attention and was able to resolve himself by drinking some cola and eating food.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The initial investigation was performed on the user synced glucose data in data management system (dms), which is a cloud platform for eversense systems.Based on the investigation analysis, system asserted low glucose alerts at 16:42 pm and 16:57 pm.However, customer did not receive alerts on their app due to tranmsitter being disconnected from phone.As this issue persisted, a return material authorization (rma) was authorized to return the transmitter for evaluation.However, the product was never received.As a result, no further investigation was possible for this incident and root cause could not be determined.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 18999370
• MDR Text Key: 338880701
• Report Number: 3009862700-2024-00267
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/27/2024

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: 01/11/2022
• Device Model Number: 102208-853
• Device Catalogue Number: FG-3400-53-101
• Device Lot Number: 122399
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1