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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2023

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where the patient was unable to link their sensor as it was inserted near their previous sensor.The patient made an appointment with their hcp to possibly have both the sensors removed.Multiple attempts were made to contact the patient for additional information.However, the patient remained unresponsive.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.A review of the device's manufacturing records was not possible due to lack of information.The insertion of new sensor was off label since it was inserted in a close proximity to the older sensor.This in turn created a signal interference issue for the patient with the new sensor as the system was detecting signal from old sensor.The most likely root cause of this incident is due to the procedural error from the inserting physician as the new one should have been inserted in the other pocket/other arm.Since the usage of the system wasn't possible due to sensors being close to each other, patient made an appointment with their hcp to possibly have both the sensors removed.Multiple attempts were made to contact the patient for additional information and to check if the sensor removal happened.However, the patient remained unresponsive.As a result, the sensor removal information is not available and no further investigation was possible.

• Brand Name: EVERSENSE SENSOR
• 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: 18117258
• MDR Text Key: 327888183
• Report Number: 3009862700-2023-00283
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• 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: 11/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other