Events

Rappel de Device Recall Medtronic MiniMed paradigm mio Infusion Sets

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
    59960
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0202-2012
  • Date de mise en oeuvre de l'événement
    2011-05-16
  • Date de publication de l'événement
    2011-11-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104110
  • 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
    Set, administration, intravascular - Product Code FPA
  • Cause
    The consignee received four (4) boxes of mio infusion sets (mmt-921) that were shipped to them in error. these infusion sets were shipped in a package that included a minimed paradigm real-time insulin pump among other items. the mio infusion sets were not authorized to be shipped to the consignee based on medtronics internal product handling procedures and they may not function properly. t.
  • Action
    The firm, Medtronic, sent an "IMPORTANT RECALL INFORMATION" letter dated May 16, 2011 to consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue use right away; use the replacement mio infusion sets provided to them in this package; return all unused Lot 3700255 mio infusion sets using the emailed pre paid return label, and drop the package off at any UPS location or call UPS at 800.742.5877 to schedule a pick up. "Please note that only the Lot 3700255 mio infusion sets were shipped in error. The other products included in the package were not shipped in error and do not need to be returned." If you have any additional questions relating to this notification or any questions in general call 800.999.9859 ext.63704.

Device

Device Recall Medtronic MiniMed paradigm mio Infusion Sets
  • Modèle / numéro de série
    Lot Number 3700255
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: AL only.
  • Description du dispositif
    Medtronic MiniMed paradigm mio Infusion Sets MMT-921 || The Paradigm mio infusion sets are intended for the subcutaneous infusion of insulin from a Medtronic MiniMed Paradigm insulin infusion pum.
  • Manufacturer
    Medtronic Minimed

Manufacturer

Medtronic Minimed
  • Adresse du fabricant
    Medtronic Minimed, 1800 Devonshire Street, Northridge CA 91325
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA