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

Model Number 102096-67A

Device Problem Installation-Related Problem (2965)

Patient Problem No Code Available (3191)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr is result of a retrospective review of complaints.The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On (b)(6) 2020, senseonics was made aware of an instance where patient experience problem in linking his newly inserted sensor leading to sensor removal and replacement.

Manufacturer Narrative

The rma was authorized but not received so no further confirmation or investigation of the complaint is possible.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown, md
• MDR Report Key: 10020997
• MDR Text Key: 189737284
• Report Number: 3009862700-2020-00290
• 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: 02/05/2020

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: 07/10/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP07368
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 05/04/2020
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR