MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SMART TRANSMITTER; IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER

Model Number 102208-850

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Transmitter was initial suspected device.However, it was not requested to be returned for evaluation as it was still being used by the user.Based on the investigation analysis on the user's data in data management system (dms), there were mismatch between the sensor readings and the fingerstick measurements which was caused due to shift in the signal modulation between november 5 and 6.Sensor was requested to be returned for evaluation.It was tested in-house but did not reveal any malfunction.The actual root cause of the issue could not be determined.The potential cause for this type of behavior in sensor performance might be due to lack of hydration of the hydrogel after insertion.

Event Description

Senseonics was made aware of an false hypoglycemia incident due to sensor inaccuracies.Patient reported that sensor glucose (sg) value was 78 mg/dl where as blood glucose (bg) measurement was 114 mg/dl.Patient received low glucose alerts because the sg value crossed the low alert threshold which was set at 80 mg/dl.Patient did not have any symptoms and did not require any medical attention.

• Brand Name: EVERSENSE SMART TRANSMITTER
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER
• 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: 19009227
• MDR Text Key: 338981464
• Report Number: 3009862700-2024-00278
• Device Sequence Number: 1
• Product Code: QCD
• 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: 03/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/16/2022
• Device Model Number: 102208-850
• Device Catalogue Number: FG-3400-50-101
• Device Lot Number: 122724
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 03/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2021
• 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