Events

Recall of Freestyle Navigator Continuous Glucose Monitor System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Diabetes Care, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52635
  • Event Risk Class
    Class 2
  • Event Number
    Z-1458-2010
  • Event Initiated Date
    2009-04-14
  • Event Date Posted
    2010-04-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90256
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Continuous glucose monitor - Product Code MDS
  • Reason
    Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.
  • Action
    Notification letters were issued to FreeStyle Navigator customers via certified mail and notification was posted on the Abbott Diabetes Care's Website. Customers were notified of the potential issue and actions to take: 1) if moisture is observed in the FreeStyle Navigator transmitter now or at any time, discontinue use of the transmitter and call Abbott Diabetes Care Customer Care at 1-800-418-6427 and 2) if a loss of connection is encountered or if your results are not reliable or are inconsistent with how you feel, consult your User's Guide for troubleshooting guidelines. If the issue is not resolved, call Abbott Diabetes Care Customer Care at 1-800-418-6421. For outside-of-US accounts, the firm's regional offices will distribute notices to identified customers in the appropriate language.

Device

Freestyle Navigator Continuous Glucose Monitor System
  • Model / Serial
    Abbott Item # PRT 03415-010 with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M0878 or 01M3018. Kit Serial numbers beginning with: BAAH 067 BAAH 093 or BAAH 107 or BAAH 156 or BAAH 200 or BAAH 207 or BAAH 275 or BAAH 290 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 139 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 248 or AAAH 288 and followed by a five (5) digit number.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.
  • Product Description
    Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number: PRT 03415-010, distributed by Abbott Diabetes Care Inc, Alameda, CA. || Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
  • Manufacturer
    Abbott Diabetes Care, Inc.

Manufacturer

Abbott Diabetes Care, Inc.
  • Manufacturer Address
    Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
  • Source
    USFDA