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

Model Number	102208-600
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Loss of consciousness (2418)
Date of Event	08/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per case notes, the user confirmed that she did not take her bg during either of the two events to confirm if she was having a low glucose event.The user reported that the user was not wearing the transmitter at the time of both events, thus the system was not in use.The user's hcp was made aware of the event and did not prescribe any medications.This adverse event was not related to the use of eversense continuous glucose monitoring system as the system was not in use.No further resolution was necessary for this complaint.
Event or Problem Description
On august 12, 2024, senseonics was made aware of an incident where the user reported two events on (b)(6) 2024.The user blacked out in the morning around 10:17am, and at night on the same day, the user's legs were giving up.The user did not take any bg measurement during these two events to see if she was having a low glucose event.

• Brand Name: EVERSENSE TRANSMITTER
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 20195491
• Report Number: 3009862700-2024-00918
• Device Sequence Number: 17862612
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 00817491022912
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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: 09/19/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 132179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 23 YR
• Patient Sex: Female