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

Model Number 102208-802

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 01/14/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Transmitter was not requested to be returned for evaluation because it was still being used by the user.The investigation was performed on the user's data available in data management system (dms).The customer's complaint of event on (b)(6) cannot be confirmed as the reported bg value was not found in the dms for that day.Also, the customer stopped using the system just about the time when the alert for low glucose on (b)(6) at 02:16 am would have been received as the glucose was trending down.Overall, the investigation didn't find any malfunction with the sensor and it is still currently in use by the customer.Patient's mother called for ambulance but patient felt better by having some sugar while her mother was on call with emergency service, so no hospitalization was required.Patient is currently using the system with better agreement in bg/sg values.No further actions were found necessary by senseonics.

Event Description

Senseonics was made aware of a hypoglycemia event due to alleged sensor inaccuracies on (b)(6) 2022 between 2 am and 3 am.User reported that blood glucose (bg) value was 4.4 mmol/l and sensor glucose (sg) value was 1.4 mmol/l.User reported to have not received low glucose alerts.The user was cold, drowsy and she did not feel well.User called ambulance, but did not go to hospital.User ate something at home and felt better.

• 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: 19009349
• MDR Text Key: 338979406
• Report Number: 3009862700-2024-00317
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: SW
• 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: 11/16/2021
• Device Model Number: 102208-802
• Device Catalogue Number: FG-3400-02-101
• Device Lot Number: 121214
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2020
• 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): Hospitalization