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 06/08/2022

Event Type  Injury  

Event Description

Senseonics was made aware of a hypoglycemia event and user complained of sensor inaccuracies.User reported that the event happened on (b)(6) 2022 at around 6 am.The measured blood glucose was 61 mg/dl and the sensor reading was 235 mg/dl.User did not receive any alerts.User was symptomatic, but did not want to provide information regarding self treatment, medical treatment or if hospitalization was required.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Based on the investigation analysis, there was a wound reported at the insertion site after the sensor was inserted on (b)(6) 2022.The wound at the insertion site was reported around the same time as the event was reported, on june 8.The wound may have contributed to temporary noise in the optical channel which in turn, may have caused temporary mismatch between the sensor readings and fingerstick measurements.Therefore the user experienced temporary differences between the sensor readings and fingerstick measurements.As the user was leaving for vacation, there was limited data following the event to analyze further.No further investigation was possible for this complaint.

• 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: 19009408
• MDR Text Key: 338980280
• Report Number: 3009862700-2024-00353
• 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: Not provided
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• 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