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	04/16/2023
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 hypoglycemia event with no alert asserted by the system due to sensor inaccuracy.
Additional Manufacturer Narrative
Based on the investigation analysis, the reported event was at 3:14 pm est on (b)(6) 2023, where the calibration entry was marked as a suspicious calibration and the system prompted for additional calibration.The calibration entries before and after the reported event (10:35 am est and 7:14 pm) est were accepted by the system.The system adjusted the sensor reading upon completion of the calibration entry at 3:14 pm est, which is one of the mechanisms to adjust sensor readings based on calibration entry.Per the analysis of the associated sensor accuracy complaint, mdr report 3009862700-2023-00111, it was captured that the sensor (b)(6) was implanted in the same location as the previous sensor, where an infection was reported.This could be the potential cause, due to the sensor taking longer to stabilize after insertion.The user was reached out to ask if the incision site has healed.However, the user was unresponsive.Due to the deviation of the sensor performance and to determine the root cause, the rma was issued in the associated sensor accuracy complaint, mdr report 3009862700-2023-00111.The rma investigation will be captured as part of mdr report 3009862700-2023-00111.The user was inserted with a new sensor (b)(6) on (b)(6) 2023, which is performing within expectations.The user didn't seek for medical treatment and resolved the event by drinking some juice.Furthermore, as part of the resolution of mdr report 3009862700-2023-00111, for the issue with sensor inaccuracies, the user was offered a sensor replacement.No further resolution was found necessary for this complaint.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: 16958955
• Report Number: 3009862700-2023-00108
• Device Sequence Number: 20144641
• Product Code: QHJ
• UDI-Device Identifier: 00817491022929
• UDI-Public: 817491022929
• 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): 04/18/2023

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: 01/27/2023
• Device Model Number: 102208-610
• Device Catalogue Number: FG-5901-01-001
• Device Lot Number: 129007
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• 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: 66 YR
• Patient Sex: Female