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

Model Number 101967-950

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 05/21/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The investigation was performed on the user synced glucose data on data management system (dms), which is an eversense cloud platform.The dms investigation analysis could not confirm the adverse event because the sensor was already retired and the system was not in use at the time of incident.The system asserted an early sensor replacement alert on (b)(6) 2023 at 10:58 am after 147 days of use.Due to early sensor retirement, a return material authorization (rma) was issued to bring back the sensor for further investigation and to determine the root cause.The returned sensor was investigated which revealed a loss of chemical performance.The eversense cgm system correctly disabled the sensor due to performance failure indicated by metric of sensor performance (msp) value going below the established threshold.The system's self test functions worked as expected by retiring the sensor.The root cause of such failure is due to the oxidation of sensor's hydrogel.No further investigation was found necessary for this complaint.

Event Description

Senseonics was made aware of an incident where the customer experienced a hyperglycemic event on (b)(6) 2023, after the sensor retired prematurely.The sensor retired a day before on (b)(6) 2023.There was no sensor glucose readings because of the early sensor retirement.The blood glucose (bg) value at the time of incident was 298 mg/dl.The customer did not seek any medical treatment.

• Brand Name: EVERSENSE SENSOR
• Type of Device: 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: 18117333
• MDR Text Key: 327888388
• Report Number: 3009862700-2023-00271
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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
• Report Date: 11/12/2023

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: 06/16/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: 6.04.04W
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other