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

Model Number 101967-950

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Malaise (2359); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2022

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where patient had issues linking the sensor with the transmitter.The patient did not get any signal with the sensor despite trying several times.Upon consulting the hcp, it was found that the sensor had not been implanted during the insertion procedure that happened on (b)(6) 2023.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The inserting hcp confirmed that the sensor had not been implanted during the insertion procedure that happened on (b)(6) 2023.This was discovered after the patient was unable to link the sensor to the transmitter despite trying several times.The sensor would have likely remained inside the insertion tool and the hcp may have forgotten to notice.This is the possible root cause of the incident.A new sensor was then inserted to the patient on (b)(6) 2023 and it was confirmed that the sensor was able to link with the transmitter successfully.The patient confirmed that the system is working fine now.No further investigation was found necessary for this complaint.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING 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: 18117330
• MDR Text Key: 327880181
• Report Number: 3009862700-2023-00256
• 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 Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2023
• 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