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

Model Number	102208-610
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/22/2024
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 around 10 or 11 am est where the user's sg was between 180mg/dl and 190 mg/dl user did not remember the bg measure.After dms review, we can see that between the hours that the user mentioned the sg was fluctuating between a minimum of 146 mg/dl and maximum of 156 mg/dl, and the bg is not available in dms.After dms review, we confirmed that the user didn't receive a low glucose alert at the time of event because the sg never went below the alert level.User didn't seek for medical treatment.User resolved the event by drinking an orange juice.
Additional Manufacturer Narrative
The user reported experiencing hypoglycemic event on (b)(6) 2024.The user mentioned that the sg at the time was 180mg/dl and 190 mg/dl and user did not remember the bg measure.A review of the data management system (dms) data revealed that between the hours that the user mentioned, the sg was fluctuating between a minimum of 141 mg/dl and maximum of 156 mg/dl, and no bg values were entered.A review of the alert history confirmed that the user didn't receive a low glucose alert at the time of event because the sg never went below the alert level.The hypoglycemic event could not be confirmed, as no bg fingerstick was entered and the user could not remember the bg measurement.Per the case notes, the user did not seek medical treatment and resolved the event by drinking an orange juice.In an associated case for the user's complaint about sensor inaccuracy (complaintrec-(b)(4)),based on initial escalation review of the available data, there was no indication of an issue with sensor health.The bg values entered as calibrations fit sg trends well.The mard of the last 14 days was 0.5%.The symptoms consistent with situations where estimated values provided by the app were entered as calibrations rather than true bg values were observed.As the user was unresponsive and doesn't want to continue troubleshooting the issue.Per dms, the user is currently using the system with no further inaccuracy cases.No further investigation was possible for this complaint.B4.Date of this report 05 december 2024.G3.Date received by the manufacturer? 05 december 2024.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 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: 20752215
• Report Number: 3009862700-2024-01075
• Device Sequence Number: 8088785
• Product Code: QHJ
• UDI-Device Identifier: 00817491022929
• UDI-Public: 00817491022929
• 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): 12/05/2024

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: 10/09/2024
• Device Model Number: 102208-610
• Device Catalogue Number: FG-5901-01-001
• Device Lot Number: 141133
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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