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

Model Number 102208-905

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 09/29/2023

Event Type  Injury  

Event Description

Senseonics was made aware of a false hyperglycemia event which happened on (b)(6) 2023 at 07:19 am and 08:29 am where the eversense cgm system provided high glucose alerts even though there were no actual hyperglycemia event.The customer reported that the sensor glucose (sg) readings were 263 mg/dl and 253 mg/dl respectively.No bg measurements were taken, but the customer was sure the bg values were not high.The customer did not have to take any actions.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The manufacturer is currently performing evaluation and the results will be provided in a supplemental report.

Manufacturer Narrative

The investigation was performed on the user synced glucose data on data management system (dms), which is an eversense cloud platform.Based on the investigation analysis, the sensor glucose (sg) value on (b)(6) 2023 at 07:19 am was 253 mg/dl and at 08:29 am, it was 251 mg/dl.The system asserted high glucose alerts at the time of incident since it crossed the high glucose alert threshold which was set at 250 mg/dl.A review of the overall system performance suggested that the system was taking longer than expected to stabilize after the insertion.Multiple mismatches were observed on (b)(6) 2023 and due to this deviation in the system performance, a return material authorization (rma) was issued for sensor replacement.As part of the standard returned product analysis, a sensor functional performance test was performed on the returned sensor following the decontamination process.This test measures the sensor's fluorescence characteristics with respect to changes in glucose solution concentrations and temperature changes, and compares the results to the performance measured during the initial manufacturing of the same sensor.Investigation of the returned sensor did not reveal any malfunction as it passed all the functional tests.This may occur in some instances where the failure mode that presents itself in the body is not reproduced in the lab.Based on the historical evidence of the similar incidents, the potential root cause of the issue could be attributed to inadequate hydration of the chemical component of the sensor.No further investigation was found necessary for this complaint.B4.Date of report updated to 01/09/2024.G3.Date received by the manufacturer updated to 26 december 2023.H3.Device evaluated by manufacturer?yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 18117303
• MDR Text Key: 327888191
• Report Number: 3009862700-2023-00303
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2023
• Device Model Number: 102208-905
• Device Catalogue Number: FG-3500-05-001
• Device Lot Number: 133445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other