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

Model Number 102208-850

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 11/10/2021

Event Type  Injury  

Event Description

Senseonics was made aware of two hyperglycemia incidents, due to sensor inaccuracies.At 6:52 pm, the bg was 213 mg/dl.Where as sg-100 mg/dl.At 7:34 pm, the bg-199 mg/dl.Where as sg-100 mg/dl.In both cases, patient did not receive high glucose alerts, because the sg value did not cross the hight alert threshold.Which, was set at 175 mg/dl.Patient did not have any symptoms.And did not require any medical attention.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Transmitter was the initial suspected device.However, upon reviewing user's data in dms, a decline in sensor performance was observed.Thus the sensor was requested to be returned for further investigation.The user's complaint of mismatches between sensor glucose readings and blood glucose readings was confirmed, via data review in data management system (dms).When the returned sensor was investigated, the in-house testing did not reveal any issue with sensor performance.Since, the issue reported by the user could not be replicated in the in-house testing, the exact root cause could not be determined.Based on historical data of similar incidents, the potential root cause could be attributed to lack of hydration of chemical component of the sensor.

• 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: 19009293
• MDR Text Key: 338981010
• Report Number: 3009862700-2024-00279
• 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: 03/31/2024

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: 03/31/2024
• 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