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

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr is a result of a retrospective review of complaints.The malfunction was not confirmed since no material was returned for investigation.

Event Description

On (b)(6) 2019, senseonics was made aware of an incident where the patient couldn't get the signal to link his sensor leading to a revision surgery to place a new sensor.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown,, md
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown,, md
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, md
• MDR Report Key: 9690904
• MDR Text Key: 183361133
• Report Number: 3009862700-2020-00091
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 37 YR