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 Code	Hypoglycemia (1912)
Date of Event	04/10/2024
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 the user reported a hypoglycemic event with no alert from the system due to inaccuracy in sensor readings.
Additional Manufacturer Narrative
The user reported a low glucose event with sg=157 mg/dl on (b)(6) 2024 at 4.30pm, and bg was not entered at the time.User reported that after they got home they took a bg= 59 mg/dl.Dms review showed sg was 70 mg/dl and bg was not entered on (b)(6) 2024 at 4.27pm.The reported bg of 59 mg/dl was confirmed at 6:21 pm and at the time sg was 83 mg/dl.Dms review, confirmed that the user didn't receive a low glucose alert at the time of the event because the sg values never went below the low alert setting at the time of incident.In associated sensor inaccuracies case, it was determined the system is working within expectations.Overall, bg values entered as calibrations fit sg trends well, with occasional differences due to lag, and calibrations entered during periods of rapid change in glucose.The customer was recommended to keep using the system, entering calibrations when glucose is stable.The customer did not seek medical treatment and treated himself by eating and drinking.Sensor readings closely matched calibrations during the two weeks following the reported event.The user is currently using the system.No further investigation was found necessary for this complaint.B4.Date of this report 24 may 2024.D4.Primary unique device identifier (udi) number updated to (b)(4).G3.Date received by the manufacturer? 24 may 2024.H3.Device evaluated by manufacturer? yes.H6.Investigation 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 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: 19293982
• Report Number: 3009862700-2024-00710
• Device Sequence Number: 7069868
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

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: 07/10/2024
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 138536
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• 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: 53 YR
• Patient Sex: Female