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

Model Number 102208-853

Device Problem Communication or Transmission Problem (2896)

Patient Problem Hypoglycemia (1912)

Event Date 11/15/2021

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where patient experienced a hypoglycemia on (b)(6) 2021 at around 08:30 am.Sensor glucose (sg) was 67 mg/dl where as bg value was not recorded.Patient received vibration via transmitter but he did not receive alert via the app as there was no connection at that time.Patient waited to see if the reconnection would happen automatically, but it did not.He drank some cola and ate a biscuit to increase glycaemic level.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.User provided 4 examples of hypoglycemia incidents that occurred on (b)(6) 2021.User received low glucose alerts and transmitter vibrations for examples two (2), three (3) and four (4) where the system performed as intended.For the example one (1), user received vibration via transmitter, but did not receive alert via the app as there was a transmitter disconnection at that time.User waited to see if there would be automatic reconnection, but that did not happen.Transmitter was requested to be returned for further evaluation.However, the product was never received.As a result, no further investigation was possible for this complaint.As part of resolution, user was given a transmitter replacement.

• 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: 19009319
• MDR Text Key: 338980381
• Report Number: 3009862700-2024-00283
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 01/11/2022
• Device Model Number: 102208-853
• Device Catalogue Number: FG-3400-53-101
• Device Lot Number: 122399
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2021
• 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