Events

Rappel de SYMPHONY GLUCOSE MANAGEMENT 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 Animas Corporation.

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
    49476
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0290-2009
  • Date de mise en oeuvre de l'événement
    2008-08-04
  • Date de publication de l'événement
    2008-11-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-02-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73523
  • 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
    Insulin infusion pump - Product Code LZG
  • Cause
    Unintentional rebooting: pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. the failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.
  • Action
    The recalling firm issued a notification letter to the patients with insulin pumps on 8/5/08 to inform them of the problem and that they needed to replace the battery. The recalling firm contacted OneTouch Ping users by telephone on 8/5/08 for this issue and another issue. The recalling firm issued letters to distributors informing them of the problem and notified customers to replace the batteries. In addition, a letter was issued to physicians to alert them of the situation with regard to current patients. Consumers can contact 1-800-423-4087 for additional information or questions.

Device

SYMPHONY GLUCOSE MANAGEMENT SYSTEM
  • Modèle / numéro de série
    Part Number: 100-158-01. All units (no serial numbers).
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand, Spain, Switzerland, and Sweden.
  • Description du dispositif
    Battery Caps used with insulin pumps and glucose monitoring systems. || The pump is used to help maintain blood glucose targets.
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation
  • Adresse du fabricant
    Animas Corporation, 200 Lawrence Dr, West Chester PA 19380
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA