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

Model Number 102208-500

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 12/29/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021, senseonics was made aware of an incident where the user experienced high glucose symptoms and had to go to the doctor's office.

Manufacturer Narrative

Investigations showed that the customer was potentially using sg values for bg calibration on previous day of event likely leading to inaccurate sensor glucose values, subsequently affecting the ability of the system to predict any potential medical event.This is not the intended use of the device.As per notes, user was symptomatic, feeling fatigue, urinarily discomfort, shortness of breath and thirst and had to go to the doctor's office, so hcp becomes aware of the event.Hcp provided medical assistance to solve the event and was treated with 20 units of insulin but no hospitalization was required.As per notes, user took 10 units of insulin and at 3:57 pm the bgm reading went down to 392 mg/dl, then at 4:20 pm it was 342 mg/dl.User went home afterwards and felt better.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 19.

• 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: 13371418
• MDR Text Key: 285346389
• Report Number: 3009862700-2022-00009
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• 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: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/17/2022
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 122703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2021
• Is the Device Single Use?: No
• 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: 29 YR
• Patient Sex: Female