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

Model Number 102208-620

Device Problem Imprecision (1307)

Patient Problems Fever (1858); Hypoglycemia (1912); Chills (2191); Shaking/Tremors (2515)

Event Date 01/29/2023

Event Type  Injury  

Event Description

On (b)96) 2023, senseonics was made aware of an incident where the user experienced a hypoglycemia event with no alert asserted by the system due to a sensor inaccuracy.

Manufacturer Narrative

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

Manufacturer Narrative

The user reported a hypoglycemia event where the system did not alert the user.A review of the data management system (dms) confirmed the user's reported glucose values.The system did not assert the low glucose alert because the sg value did not cross the alert threshold that was set at 65 mg/dl.However, the system asserted the low glucose alert when the sg value reached 59 mg/dl.To address the user's concern with sensor inaccuracies, sensor performance was further reviewed.The review of the diagnostic upload (du) and the data available on dms confirmed the system was working within expectations.Overall, bg values fit glucose trends well, with occasional differences due to lag and calibrations entered during periods of rapid change in glucose.The user was suggested to consider enabling predictive alerts in the app so that he can be alerted before reaching a certain glucose level.The user was advised to consult his hcp to discuss this.The user acknowledged understanding all of the provided information.The user resolved the hypoglycemic incident by eating crackers and drinking flavored water.The user is currently using the system with up-to-date information.B3.Date of event updated to 29 january 2023.B4.Date of this report updated to 31 january 2023.H3.Device evaluated by manufacturer? yes.H6.Investiagtion findings updated to 213.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 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: 16463869
• MDR Text Key: 310490544
• Report Number: 3009862700-2023-00053
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022936
• UDI-Public: 817491022936
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/21/2023
• Device Model Number: 102208-620
• Device Catalogue Number: FG-5902-01-001
• Device Lot Number: 129013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2022
• 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 Age: 69 YR
• Patient Sex: Male