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

Model Number 101967-710

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

Patient Problem Implant Pain (4561)

Event Date 08/30/2020

Event Type  Injury  

Event Description

Senseonics was made aware of an instance where patient experienced pain in the inserted arm.On night of august 30th and 31st he woke up because the arm where sensor was inserted was aching.He removed the transmitter and saw something sticking out of his arm which turned out to be the sensor.Apparently the incision was not fully healed.He visited doctor at eversense center.The doctor pulled out the sensor, and then made a new pocket at the same incision and placed the same sensor back.

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.Hence, there was no malfunction with the device.The actual root cause of the incident, however, could not be determined.The probable root cause could be sensor placement not being ideal and too near to the epidermis and/or insertion site not completely healed.Distributor was informed that a sensor sticking out should never be inserted back unless removed directly from the sensor holder with the insertion tool and in the normal manner, as any other case would likely damage the sensor chemistry and interfere with the correct orientation of the sensor.Also a non sterile sensor could lead to multiple problems including infection, sepsis etc.Distributor agreed to convey this to the doctor.

• Brand Name: EVERSENSE SENSOR
• 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: 18571056
• MDR Text Key: 333605486
• Report Number: 3009862700-2024-00147
• Device Sequence Number: 1
• Product Code: QCD
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2024

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: 09/13/2020
• Device Model Number: 101967-710
• Device Catalogue Number: FG-4400-10-302
• Device Lot Number: WP06529
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2019
• 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