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

Model Number	102208-620
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Fever (1858); Hypoglycemia (1912); Chills (2191); Shaking/Tremors (2515)
Date of Event	01/29/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Additional 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
• Common Device Name: 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
• Report Number: 3009862700-2023-00053
• Device Sequence Number: 17770991
• Product Code: QHJ
• UDI-Device Identifier: 00817491022936
• UDI-Public: 817491022936
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male