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	Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
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) 2024, senseonics was made aware of an incident where user reported a low glucose event on (b)(6) 2024 at 03:16 pm where sg was 62mg/dl.After dms review, we confirmed the following information at the time of the event and we confirmed that the user received a low glucose alert at 3:16 pm est, when the sg was at 62mg/dl.User didn't seek for medical treatment as he stated he was not having a low.User's hcp is aware of the event, no medication was prescribed.
Additional Manufacturer Narrative
The user reported receiving low glucose on 24-oct-2024.The user mentioned that the sg was 62 mg/dl.A review of the data management system (dms) data revealed that on 24-oct-2024 at 03:16 pm sg was 62 mg/dl and no bg was entered.A review of the alert history indicated that the user did receive a low glucose alert at 03:16 pm, when the sg was at 62mg/dl.The user did not seek medical treatment and believed that they were not having a low glucose event.The user's hcp was not aware of the event.The user was advised to follow up with their hcp for any necessary medical guidance.In an associated case for the user's complaint about sensor inaccuracy (complaintrec-51489), review of the data revealed that the user was entering estimated values provided by the app as calibrations rather than true bg values.The user was advised that they should never enter anything other than a true bg meter value, from a finger stick, when calibrating.The user understood the advice and started entering true fingerstick values while calibrating the system.An additional review of the system after the event revealed that sg values were in good agreement with bg values entered.The user did not take any action as the user did not have any hypoglycemic symptoms.B4.Date of this report 22 december 2024.G3.Date received by the manufacturer? 20 december 2024.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 19.

• 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: 20873906
• Report Number: 3009862700-2024-01103
• Device Sequence Number: 20988199
• 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
• Device Implanted Year: 2024
• 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): 12/22/2024

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: 12/04/2024
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 143125
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/07/2024
• Supplement Report FDA Received Date: 12/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Male