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

Model Number 101967-950

Device Problem Imprecision (1307)

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

Event Date 11/15/2022

Event Type  malfunction  

Event Description

On 15th november 2022,senseonics was made aware of an incident where a user experienced sensor inaccuracy which led to early sensor removal.

Manufacturer Narrative

Based on the initial escalation analysis, due to impact to the sensor reported at the time of the reported event, affected the sensor performance and the user experienced temporary accuracy issues.Due to the external impact to sensor, it could not be guaranteed if the sensor would recover to its optimal level of performance.Per the analysis, the rma was authorized.Upon receipt of the rma, the sensor was tested in-house, and the customer's complaint could not be reproduced during the in-vitro testing, and did not reveal any malfunction.

Manufacturer Narrative

H11 corrected to,"based on the initial escalation analysis, there was impact to the sensor at the time of the event that affected the sensor performance and caused the user to experience temporary mismatch.Due to the external impact, the sensor was likely to not recover to its optimal level of performance.An rma was authorized to have the sensor returned for further investigation.The investigation indicated that there was no malfunction observed in the system, and the failure mode (performance deviation) could not be reproduced via in-vitro testing.The user received a new sensor as courtesy from the distributor".H6.Investigation conclusions updated to 67.

Manufacturer Narrative

The user reported sensor reading inaccuracies around 14 october 2022.Based on the initial escalation analysis, the sensor performance deviated from normal behavior.An rma was authorized for further investigation.Upon receipt of the sensor, the return product analysis testing was performed, however, the return sensor did not reveal any malfunctions.In an associated complaint (b)(4), the user's hcp reported an infection at the insertion site on 14th october 2022.This infection potentially could have impacted the sensor performance causing the reported sensor reading inaccuracy.As part of resolution, the user received a sensor replacement.B4.Date of this report updated to 11 april 2024.G.Date received by the manufacturer ? 10 april 2024.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 22.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• 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: 19009139
• MDR Text Key: 338989212
• Report Number: 3009862700-2024-00391
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023308
• UDI-Public: 817491023308
• 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,Followup,Followup
• Report Date: 04/11/2024

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 Expiration Date: 04/14/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP08959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• 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