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	Hypoglycemia (1912)
Date of Event	02/15/2023
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 incident where the user experienced a hypoglycemia event with no alert asserted by the system due to a sensor inaccuracy.
Additional Manufacturer Narrative
Based on the investigation analysis, the reported event on (b)(6) 2023, at 11:33 am est, displayed a temporary mismatch between the sensor reading and calibration entry.The user did not receive a hypoglycemia alert at the time of the event because the sensor reading did not cross the hypoglycemia alert threshold set by the user.Prior to the event, there was a calibration entry of 101 mg/dl at 9:16 am est entered, which closely matched the sensor reading of 101 mg/dl at the time of the reported event.It could not be confirmed if the calibration was performed in error as the subsequent calibration entered at 11:33 am est displayed a mismatch followed by 4 consecutive suspicious calibrations which led the system to go into a sensor suspend phase.In the sensor suspend phase, the system recalibrated its glucose calculation algorithm while the sensor readings were blinded to the user for 6 hours.After the sensor suspend phase, the system re-started in the initialization phase and started displaying better agreement between the sensor readings and fingerstick measurements, with its overall performance within expectations.Although the reported blood glucose (bg) at the time of event was in the normal glucose range, the user took a remedial action by drinking coke and eating grapes.The user did not seek any medical attention.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• 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: 16562928
• Report Number: 3009862700-2023-00067
• Device Sequence Number: 5895561
• 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): 02/15/2023

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: 01/28/2023
• Device Model Number: 102208-620
• Device Catalogue Number: FG-5902-01-001
• Device Lot Number: 129004
• 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: 02/15/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Female