Events

Retiro De Equipo (Recall) de HemoCue Glucose 201 RT and Glucose 201 DM RT Systems (An in vitro diagnostic medical device (IVD) for the quantitative detection of blood glucose)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por HemoCue Australia Pty 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-2013-RN-00279-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-03-28
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00279-1
  • 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
    During extended investigations on neonates it was confirmed that hemocue glucose 201 rt and hemocue glucose 201 dm rt perform according to specifications in all neonatal settings except neonatal intensive care. critically ill neonates in intensive care settings often have immature metabolism in combination with complex treatment. this setting has not been fully evaluated for hemocue glucose 201 rt and glucose 201 dm rt. incorrect readings may lead to indirect harm to patients such as misdiagnosis or inappropriate treatment. therefore the following text will be added to the intended use: "the system should not be used on critically ill neonates in neonatal intensive care settings".
  • Acción
    HemoCue is enclosing adhesive labels with the updated intended use along with the customer letters so that end users can use this to cover the current intended use in the Operating Manual, Technical Specifications etc.

Device

HemoCue Glucose 201 RT and Glucose 201 DM RT Systems (An in vitro diagnostic medical device (IVD)...
  • Modelo / Serial
    HemoCue Glucose 201 RT and Glucose 201 DM RT Systems (An in vitro diagnostic medical device (IVD) for the quantitative detection of blood glucose)
  • Manufacturer
    HemoCue Australia Pty Ltd

Manufacturer

HemoCue Australia Pty Ltd
  • Source
    DHTGA