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

Model Number 102096-67A

Device Problem Material Separation (1562)

Patient Problem Discomfort (2330)

Event Date 07/07/2022

Event Type  Injury  

Manufacturer Narrative

As per notes, the clamp slipped off the sensor and the cap came off which required another step to retrieve the cap.The entire sensor was removed, there was no harm to the patient and the sensor will be returned to senseonics for analysis.Rma-18452 was created for return of product without replacement.As per notes, user was doing fine.No further resolution was found necessary for this complaint.

Event Description

On (b)(6) 2022, senseonics was made aware of an adverse event where users sensor broke during the removal procedure.

Manufacturer Narrative

Upon reception of the rma, a visual inspection confirmed the customer's complaint.Pictures do show that the end cap of the sensor popped off while it was being explanted.Though the end cap was not received in-house with the rma, the case note confirms that fragments of broken sensor were successfully removed.Bubbles were observed close to the cap interface.Forcep marks were visible on the edge of the sleeve where cap came off.Breakage of sensor during removal is a known and anticipated potential adverse effect, which does not require additional investigation.Per case notes, sensor fragments were successfully removed.There was no harm to the user.User is doing fine.No further resolution was found necessary for this complaint.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 15214474
• MDR Text Key: 297759733
• Report Number: 3009862700-2022-00125
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/05/2021
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP08273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• 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 Age: 20 YR
• Patient Sex: Female