Freestyle Navigator Continuous Glucose Monitoring System

• 20 recalls, same reason

  • Terminated Z-1460-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1457-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1454-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1446-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1461-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1455-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1456-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1458-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-0820-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1447-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1452-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1448-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1450-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1459-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1444-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1451-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1453-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1449-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-0821-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020
  • Terminated Z-1445-2010 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared PMA P050020

  Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.

• • Terminated Z-1196-2009 FDA Unclassified (pre-2012) ·initiated 1 Nov 2008 ·on shared PMA P050020

  The product has the Units of Measure set to mmol/L rather than mg/dL. The blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade Name

Freestyle Navigator Continuous Glucose Monitor

Generic Name

Sensor, glucose, invasive

PMA Number

P050020 ↗

510(k) Number

K060383 ↗

FDA Product Code

CFR

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Architect 01G06-01

  Class I

  GUDID on market

• Architect 03M7401

  Class I

  GUDID on market

• Alinity 06P0107

  Not classified

  GUDID on market

• Alinity 06P0161

  Not classified

  GUDID on market

• Alinity 06P0115

  Not classified

  GUDID on market

• Alinity 06P0125

  Not classified

  GUDID on market

See all devices from Abbott Laboratories →

• What is the intended use of the Freestyle Navigator Continuous Glucose Monitoring System?

  The Freestyle Navigator Continuous Glucose Monitoring System is indicated for continually recording interstitial fluid glucose levels in people (ages 18 and older) with diabetes mellitus for the purpose of improving diabetes management. It is intended to be used in both home settings to help patients predict and detect episodes of hypoglycemia and hyperglycemia, and in clinical settings to assist healthcare professionals in evaluating glucose control.

• How should the readings from the Freestyle Navigator system be used in diabetes management?

  Readings and alarms about glucose levels from the Freestyle Navigator Continuous Glucose Monitoring System are not intended to replace traditional blood glucose monitoring. Before adjusting therapy for diabetes management based on the results and alarms from this system, traditional blood glucose tests must be performed. The system provides a built-in blood glucose meter to confirm the continuous glucose result.

• Is the Freestyle Navigator Continuous Glucose Monitoring System approved by regulatory authorities?

  The Freestyle Navigator Continuous Glucose Monitoring System has received FDA approval, as indicated by the FDA_PMA authorization in its regulatory history. The device was approved through the PMA (Premarket Approval) process with the approval number P050020, and it was determined to be substantially equivalent to other devices in its class.