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 Code	Hyperglycemia (1905)
Date of Event	01/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
On (b)(6) 2023, senseonics was made aware of an adverse event where user experienced hyperglycemia symptoms.
Additional Manufacturer Narrative
Based on the investigation analysis, estimated values provided by the app were entered as calibrations instead of the customer using their true bg values.Entering an estimated value or accepting the value from the eversense cgm system instead of entering a true, measured, bg value can disrupt the calibration and lead to significant deviations in sensor readings.The estimated bg values impacted the accuracy of the sensor readings and led to missing a potential medical adverse event.The user did not seek any medical attention and was able to self-treat for hyperglycemia.The user was educated about the importance of performing calibrations using true fingerstick bg values.Once the user understood the importance of proper calibration and the sensor passed the early wear adjustment period, the system began displaying good agreement between the sensor readings and calibration entries.User is currently using the system and no further investigation was found necessary for this complaint.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 18.

• 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: 16309081
• Report Number: 3009862700-2023-00029
• Device Sequence Number: 6792507
• 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): 01/08/2023

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: 02/09/2023
• Device Model Number: 102208-620
• Device Catalogue Number: FG-5902-01-001
• Device Lot Number: 129006
• 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: 01/08/2023
• Supplement Date Received by Manufacturer: 01/08/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 04/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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: 59 YR
• Patient Sex: Female