Events

Retiro De Equipo (Recall) de MiniMed 620G Insulin Pump

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 Inc..

¿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
    72352
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0437-2016
  • Fecha de publicación del evento
    2015-12-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140714
  • 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
    Pump, infusion, insulin, to be used with invasive glucose sensor - Product Code OYC
  • Causa
    The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. possible cause is either lack of greasing or deficient greasing in a ball bearing assembly of the motor.
  • Acción
    Medtronic sent an Urgent Medical Device Recall Notification dated September 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters stated that the pump drive motors may experience a malfunction which would result in a pump error message alarm notifying the patient that insulin is no longer being delivered. The letters also inform the customers of what actions are to be taken. Customers with questions are instructed to contact Medtronic MiniMed's customer support team. For further questions please call (818) 576-4700.

Device

MiniMed 620G Insulin Pump
  • Modelo / Serial
    NG1019903H NG1019906H NG1019907H NG1019909H NG1019914H NG1019915H NG1019916H NG1019918H NG1019921H NG1019922H NG1019923H NG1019925H NG1019926H NG1019928H NG1019930H NG1019931H NG1019932H NG1019933H NG1019935H NG1019937H NG1019939H NG1019940H NG1019943H NG1019944H NG1019946H NG1019949H NG1019950H NG1019953H NG1019966H NG1019971H NG1019975H NG1019976H NG1019979H NG1019981H NG1019989H NG1019997H NG1019999H NG1020001H NG1020006H NG1020007H NG1020012H NG1020015H NG1020017H NG1020018H NG1020019H NG1020020H NG1020022H NG1020023H NG1020026H NG1020027H NG1020028H NG1020029H NG1020031H
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Internationally Distribution only to the countries of : Australia, Austria, Belgium, Chile, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, India, Ireland, Italy, Japan, Kenya, Luxembourg, Namibia, Netherlands, Norway, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom.
  • Descripción del producto
    MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 || The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump system is indicated for continuous monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes.
  • Manufacturer
    Medtronic MiniMed Inc.

Manufacturer

Medtronic MiniMed Inc.
  • Dirección del fabricante
    Medtronic MiniMed Inc., 18000 Devonshire St, Northridge CA 91325-1219
  • 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