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

Model Number 102096-67A

Device Problem Failure to Sense (1559)

Patient Problem No Information (3190)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On (b)(6) 2019, the patient experienced an early sensor retirement thereby requiring early removal of the inserted device.

Manufacturer Narrative

The sensor was investigated and the issue was confirmed during investigation in-house.The investigation shows the system correctly disabled the sensor due to performance failure (low overall glucose signals leading to msp) and the system's self-test functions are working normally.Msp failures were investigated, which determined the root cause of these failures to be sensor oxidation.This sensor has the same failure mode and additional investigation is not necessary for this complaint.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONCS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• MDR Report Key: 9555472
• MDR Text Key: 183567077
• Report Number: 3009862700-2020-00008
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• Combination Product (y/n): N
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/13/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP06631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR