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-1460-2010
  • 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=90266
  • 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 03831-002 with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: AB000020 or AB000021 or AB000021.2 or AB000023 or AB000024 or AB000025 or AB000026 or AB000027 or AB000029 or AB000030 or AB000031 or AB000032 or AB000033 or AB000034 or AB000035 or AB000036 or AB000037 or AB000040 or AB000041 or AB000042 or AB000044 or AB000046 or AB000047 or AB000048. Kit Serial numbers : NA. Tx Serial numbers beginning with: AAAH 090 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH 195 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 and followed by a five (5) digit number. Tx Serial numbers AAAK 008 followed by a 5 digit number for Lot numbers AB000047 and AB000048 only.
  • 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, Assy, Transmitter Poly Contac, Abbott Item Number: PRT 03831-002, 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