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

Model Number 102208-600

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 12/25/2023

Event Type  malfunction  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On (b)(6) 2024, senseonics was made aware of an event where the user experienced a "shock" on the insertion area when wearing the transmitter.The user described the shook as feeling, "like static" and only felt it three or four times since the event happened while wearing the transmitter.

Manufacturer Narrative

The rma was authorized but not received, thus no confirmation or investigation of the complaint was possible.As part of resolution, the rma was authorized to offer the user a transmitter replacement.B4.Date of this report 02 april 2024 h3.Device evaluated by manufacturer? no h6.Type of investigation updated to 4114 h6.Investigation findings updated to 3221 h6.Investigation conclusions updated to 67.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 18628661
• MDR Text Key: 334370940
• Report Number: 3009862700-2024-00066
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 817491022912
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/26/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 134543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/26/2022
• 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: 38 YR
• Patient Sex: Male