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

Model Number 102208-600

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 01/10/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, senseonics was made aware of an adverse event where the user reported false hyperglycemia due to sensor inaccuracies.

Manufacturer Narrative

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

Manufacturer Narrative

Based on the investigation analysis, the reported mismatch between bg and sg on (b)(6) 2023, could not be confirmed due to missing data referenced by the user, but a similar mismatch was observed that day.However, it was observed that there was transient noise in the optical channel 2 days before the event, likely impacted by the condition of the hydrogel, though unclear, at the time in-vivo.There was no sign of sensor malfunction that would result in the temporary mismatch reported on (b)(6) 2023.Thus, the exact cause of the reported event could not be determined.Temporary mismatch could occur if past calibrations entered were not accurate, or the calibration on the day of the event was reported in error, or it could be due to occasional differences that the system produces.The overall sensor performance was evaluated, and it was performing within expectations.The user did not seek any medical attention or self-treatment.The user is currently using the system with up-to-date information and no further investigation is required.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 67.

• 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: 16314895
• MDR Text Key: 308973609
• Report Number: 3009862700-2023-00038
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/26/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 129861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2022
• 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 Age: 62 YR
• Patient Sex: Male