Events

Retiro De Equipo (Recall) de Device Recall MiniMed 620G, MiniMed 640G

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 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
    76436
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1890-2017
  • Fecha de inicio del evento
    2017-01-31
  • Fecha de publicación del evento
    2017-04-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153210
  • 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
  • Causa
    Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. when the software anomaly occurs it leads to battery depletion and pump shutdown.
  • Acción
    A urgent medical device recall letter was sent to customers on 1/31/17 to inform them that Medtronic has identified a software issue that could prevent the internal battery of the pump from charging. Customers are informed that should the software issue occur, an alarm is triggered and they will see the following message displayed on the pump screen: "Power error detected 00:00 25 Delivery stopped. Record your settings by uploading to CareLink or write your settings on paper. See user guide. OK." Customers are informed that If they experience the alarm and see the Power error detected message on their pump accompanied by the number 25, then they are instructed to contact the Medtronic HelpLine team at XXXXX for assistance with troubleshooting the error.

Device

Device Recall MiniMed 620G, MiniMed 640G
  • Modelo / Serial
  • Distribución
    Europe, Australia, Japan, Singapore
  • Descripción del producto
    MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • Dirección del fabricante
    Medtronic Inc., 18000 Devonshire Street, 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