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

Model Number 102208-902

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 01/26/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The investigation was performed on the user synced data on data management system (dms) which is a cloud platform for the glucose data.A review of the sensor data two (2) weeks leading up to the date of event did not indicate any performance issues, as the sensor readings were matching closely with calibration entries.The investigation showed that around the date/time of the reported event, the system did assert a predicted low glucose alert at 06:12 pm.Also the difference between the sensor glucose vs hcp measured blood glucose (4.7 mmol vs 4.0 mmol) at the time of the event was within the acceptable range.Once the user resumed use of the system after the incident, the overall sensor performance was within expectations.No further investigation was found necessary for this complaint.

Event Description

Senseonics was made aware of a serious adverse event where the patient collapsed and was hospitalized possibly due to a hypoglycemia event as diagnosed by the doctor.The event occurred on (b)(6) 2023 at around 6 pm.The measured blood glucose (bg) value at 6.12 pm was 4,0 mmol/l (taken after the event) and the corresponding sensor glucose(sg) value was 4,7 mmol/l.Per case information, the patient received glucose treatment at the hospital.Patient wasn't prescribed any medication.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 18116926
• MDR Text Key: 327882451
• Report Number: 3009862700-2023-00222
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: SW
• 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: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/07/2023
• Device Model Number: 102208-902
• Device Catalogue Number: FG-3500-02-101
• Device Lot Number: 130555
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• 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): Hospitalization