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

Model Number 102208-600

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 05/09/2023

Event Type  Injury  

Event 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 an inaccuracy in sensor readings.

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Manufacturer Narrative

Based on the initial escalation analysis, the reported event around 5:30am on (b)(6) 2023, could not be confirmed as there was no corresponding calibration entry by the user at the time.However, the analysis observed that there were some mismatches between the sensor readings and calibration entries in the period between (b)(6) and (b)(6) 2023.Based on the other complaint reported from this user in the same time period, (b)(4) (3009862700-2023-00122), the user had an infection at the insertion site which was confirmed by the user's doctor who recommended removal of the sensor.Based on the investigation findings, it is likely that the sensor performance was impacted by the infection at insertion site.The user did not require medical assistance for the hypoglycemia event and was able to self-treat by drinking gatorade.H3.Device evaluated by manufacturer?yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 22.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: 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: 17076336
• MDR Text Key: 316659729
• Report Number: 3009862700-2023-00136
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 817491022912
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 129745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Sex: Male