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

Model Number 102208-750

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 11/02/2021

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where patient experienced a hyperglycemia issue due to sensor inaccuracies on (b)(6) 2021 at 7:14 pm.Patient mentioned that the sensor glucose (sg) value was 190 mg/dl where as blood glucose (bg) value was 226 mg/dl.Patient complained to have not received high glucose alerts and transmitter vibration because the glucose value did not cross the high alert threshold of 200 mg/dl.Patient did not require any medical attention or intervention because of no symptoms.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Senseonics was made aware of an incident where patient experienced a hyperglycemia issue due to sensor inaccuracies on (b)(6) 2021 at 7:14 pm.Patient mentioned that the sensor glucose (sg) value was 190 mg/dl where as blood glucose (bg) value was 226 mg/dl.Patient complained to have not received high glucose alerts and transmitter vibration because the glucose value did not cross the high alert threshold of 200 mg/dl.Patient did not require any medical attention or intervention because of no symptoms.

• 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: 19009210
• MDR Text Key: 338981344
• Report Number: 3009862700-2024-00275
• 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: 12/18/2021
• Device Model Number: 102208-750
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 121788
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 03/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2020
• 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