Events

Rappel de Freestyle Navigator Continuous Glucose Monitor System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Abbott Diabetes Care, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    52635
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1457-2010
  • Date de mise en oeuvre de l'événement
    2009-04-14
  • Date de publication de l'événement
    2010-04-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-03-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90255
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Continuous glucose monitor - Product Code MDS
  • Cause
    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
  • Modèle / numéro de série
    Abbott Item # PRT 03415-001 with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M0168 or AB000003 or AB000004 or AB000005 or AB000006 or AB000007 or AB000008 or AB000009 or AB000010 or AB000011 or AB000012 or AB000013 or AB000014 or AB000015 or AB000016 or BAAH186 or BAAH 223 or BAAH 243 or THPK 018. Kit Serial numbers beginning with: BAAH 067 BAAH 093 or BAAH 107 or BAAH 156 or BAAH 162 or BAAH 180 or BAAH 181 or BAAH 186 or BAAH 188 or BAAH 207 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 261 or BAAH 299 or BAAH 312 or BAAH 341 or BAAG 299 or BAAG 312 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 055 or AAAH 090 or AAAH 139 or AAAH 158 or AAAH 179 or AAAH 181 or AAAH 187 or AAAH 212 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 248 or AAAH 268 or AAAH 283 or AAAH 296 or AAAH 354 or AAAK 307 and followed by a five (5) digit number.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Freestyle Navigator Continuous Glucose Monitor System, System Kit, Business 1, (Orange). Abbott Item Number: PRT 03415-001, 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.
  • Adresse du fabricant
    Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
  • Source
    USFDA