Retiro De Equipo (Recall) de CONTOUR NEXT control solutions. In vitro diagnostic medical device (IVD). MiniMed Paradigm insulin infusion pumps, MiniMed NGP Pumps, MiniMed Guardian Monitor REAL-Time and CONTOUR NEXT test strips.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bayer Australia Ltd.

¿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
    RC-2015-RN-00746-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-08-27
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Contour next control solutions. in vitro diagnostic medical device (ivd)contournext control solutions are used with contour next test strips andcontournext family meters (contour xt/next ez, contour next, contour next link, contour next link 2.4, contour next usb), medtronic minimed paradigm insulin infusion pumps, minimed ngp pumps medtronic minimed guardian monitor real-time . all lots of control solution are affectedartg number: 191635.
  • Acción
    Bayer is notifying healthcare professionals of changes to the instructions for use. The additional instructions provide detailed information on the proper handling of Contour Next controls. Bayer is also notifying health care professionals that if a CONTOUR NEXT control test result is outside of the control range, make sure to follow the instructions above, and perform another control test.

Device

  • Modelo / Serial
    CONTOUR NEXT control solutions. In vitro diagnostic medical device (IVD).MiniMed Paradigm insulin infusion pumps (MMT- 512, MMT-712, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT- 523, MMT523K, MMT-723, MMT-723K, MMT-551, MMT-751, MMT-554 and MMT-754), MiniMed NGP Pumps (MMT-1510, MMT-1511, MMT-1512, MMT-1580, & MMT- 1712), MiniMed Guardian Monitor REAL-Time (CSS7100 & CSS7200) and CONTOUR NEXT test strips. All lots of control solution are affected.
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA