Events

Retiro De Equipo (Recall) de Roche Accu-Chek Inform 11 Base Unit and Handheld Base Unit

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por manufacturer #1479.

¿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
    20444
  • Fecha de inicio del evento
    2016-07-28
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Causa
    Some accu-chek® inform ii base units (bu) and handheld base units might produce transmission errors in the form of data loss in the usb communication between the meter and the dms; for example, cobas it 1000 or any other 3rd party software. this could happen in rare cases when the base unit is connected via usb connection to a pc. this may be indicated by numerous (nonspecific) error messages sent from the meter to the dms in the form of unexpected software failure 11800 events.
  • Acción
    Software to be upgraded

Device

Roche Accu-Chek Inform 11 Base Unit and Handheld Base Unit
  • Modelo / Serial
    Model: 05060290001 and 04805658001, Affected: , Software version: 3.00.00
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479