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

Catalog Number FG-4500-50-302

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2023

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where the customer had issues with linking sensor to the transmitter because of presence of multiple sensors in the same arm.The customer reported that during the most recent sensor insertion, the hcp could not remove the old sensor and inserted the new sensor in the same arm resulting in the issue.The customer was recommended to return to their hcp and discuss the possibility of removing the old sensor or all the sensors if unable to remove just the old sensor.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.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, it was recommended to discuss with hcp about the possibility of removing the old sensor or all sensors.The hcp has scheduled to remove the sensor(s) on (b)(6) 2023.As part of resolution, the hcp will be retrained on the insertion procedure to avoid causing the error from happening again.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows pkwy; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows pkwy; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows pkwy; germantown, MD 20876-7005
• MDR Report Key: 18117373
• MDR Text Key: 327880201
• Report Number: 3009862700-2023-00297
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 11/12/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2023
• 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