Events

Retiro De Equipo (Recall) de Device Recall Medtronic MiniMed paradigm mio Infusion Sets

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Minimed.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    59960
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0202-2012
  • Fecha de inicio del evento
    2011-05-16
  • Fecha de publicación del evento
    2011-11-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104110
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Set, administration, intravascular - Product Code FPA
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Lot Number 3700255
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: AL only.
  • Descripción del producto
    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
  • Dirección del fabricante
    Medtronic Minimed, 1800 Devonshire Street, Northridge CA 91325
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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