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

Model Number 102208-610

Device Problem Imprecision (1307)

Patient Problems Diarrhea (1811); Diabetic Ketoacidosis (2364); Movement Disorder (4412)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

According to the user, the event happened around 11am on (b)(6) 2023.On the day of event, the system triggered a calibration expired alert at 3:30am est, and due to the system not being calibrated on time by the user, there was no sensor glucose readings from the day of event to (b)(6) 2023 at 2:01pm est when the user resumed usage of the system by entering the first calibration entry in initialization phase.The user did not provide further information regarding treatment or medication prescribed.User's hcp is aware of the event.Per dms, the user is currently using the system with up-to-date information.

Event Description

On (b)(6) 2023, senseonics was made aware of an adverse event where the user was hospitalized due to feeling lethargic, followed by puking, diarrhea and ketoacidosis on (b)(6) 2023.The user was admitted to the icu because of loss of neurological control.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 16881824
• MDR Text Key: 314708645
• Report Number: 3009862700-2023-00102
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022929
• UDI-Public: 817491022929
• 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
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/18/2023
• Device Model Number: 102208-610
• Device Catalogue Number: FG-5901-01-001
• Device Lot Number: 129743
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 35 YR
• Patient Sex: Female