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

Model Number 102208-751

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 05/21/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The transmitter was not requested to be returned for evaluation as it was still being used by the user.The investigation was performed on the user's data available in data management system.Based on the investigation analysis, there was temporary mismatch between the sensor readings and the fingerstick measurements due to the sensor trying to settle after insertion.The hyper alert was asserted incorrectly around time of the reported event.Following the event, as the sensor settled, the system displayed more accurate sensor readings which closely matched the fingerstick measurements.The sensor performance returned to within expectations and there was no malfunction observed following the event.No further investigation was found necessary for this complaint.

Event Description

Senseonics was made aware of a hypoglycemia event and complained of sensor inaccuracies.User reported that the event happened on (b)(6) 2022 between 9 pm and 11 pm.The measured blood glucose was 49 mg/dl at 11:04 pm and the sensor was basically giving "out of range high glucose" alerts at 10:48 pm and 11:08 pm.User was symptomatic (felt dizzy and weak), but did not seek any medical attention and was able to resolve with oral glucose.

• 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: 19009394
• MDR Text Key: 338980851
• Report Number: 3009862700-2024-00349
• Device Sequence Number: 1
• Product Code: QCD
• 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
• 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: 10/07/2022
• Device Model Number: 102208-751
• Device Catalogue Number: FG-3400-51-001
• Device Lot Number: 127178
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2022
• 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): Other