Events

Rappel de Medtronic MiniMed Paradign Insulin Infusion Pumps

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 Medtronic MiniMed.

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
    37944
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1007-2007
  • Date de mise en oeuvre de l'événement
    2007-04-27
  • Date de publication de l'événement
    2007-07-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52313
  • 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 Pumps - Product Code LZG
  • Cause
    Exposure to magnetic resonance imaging (mri) has resulted in damage to the component that monitors and controls movement of the motor in the minimed paradigm insulin infusion pump. although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemi.
  • Action
    Firm mailed Medical Device Safety letters on April 24, 2007, to healthcare professionals, existing pump users and MRI facilities reiterating the existing warning in the pump User Guide to avoid exposing the pump to MRI (or similar high strength electromagnetic fields) and strengthening previous warning by specifically mentioning the potential for over-delivery and severe hypoglycemia. Firm is also including an insert with this information with any Paradigm infusion pumps shipped to new customers.

Device

Medtronic MiniMed Paradign Insulin Infusion Pumps
  • Modèle / numéro de série
    "All serial numbers" for the following Paradigm models: MMT-51 1, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: USA, US Virgin Islands, Antigua, Australia, Austria, Bahamas, Bahrain, Bermuda, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Dominican Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela.
  • Description du dispositif
    Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722
  • Manufacturer
    Medtronic MiniMed

Manufacturer

Medtronic MiniMed
  • Adresse du fabricant
    Medtronic MiniMed, 18000 Devonshire St, Northridge CA 91325-1219
  • Source
    USFDA