MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 101967-950

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2022

Event Type  malfunction  

Event Description

Senseonics was made aware of an incident where the customer was unable to use the system normally as the app frequently gave the message "use the glucometer to make treatment decisions".The message displays on an orange background, for about 5min, then disappears.While the message is displayed, glucose levels are grayed out and trend arrows are not visible.A review of the user's system suggested a deviation in performance due to which a return material authorization (rma) was issued for sensor replacement.The incident resulted in early sensor removal.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The rma was authorized, but was not received.Thus, no confirmation or investigation of the complaint was possible.As part of resolution, the rma was issued for sensor replacement.No further investigation was found necessary for this complaint.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 19009055
• MDR Text Key: 339129645
• Report Number: 3009862700-2024-00385
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: PL
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP08952
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1