Events

Retiro De Equipo (Recall) de USB Communication Data Loss – Handheld Base Unit and Accu-Chek Inform II Base Unit

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

¿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-2016-RN-00221-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-01
  • 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-2016-RN-00221-1
  • 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
    Some handheld base units (hbu), used for coaguchek professional meters, cobas h 232 meters and usb communication data loss – handheld base unit, might produce transmission errors in the form of data loss in the usb communication between the meter and the dms. 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 sw failure 11800 events.This issue can lead to the data loss, or in the worst case, to an erroneous assignment of the patient data (patient mismatch). in case of a patient mismatch, taking into account difficult detectability of this issue, a serious medical adverse event cannot be excluded.
  • Acción
    A mandatory software update for the “Roche HBU/BU Control Panel” will be required once released by Roche. Until this is available, please do not use the USB connectivity option without further precautions. Roche suggests implementing one of the below workarounds: ·Switch the connectivity method to Ethernet (TCP/IP) or Wi-Fi. ·Install a USB hub or an active USB-repeater to improve the USB signal, to significantly reduce the potential transmission errors. One of these is required per USB connection and the software update will still be required. ·Due to some variances in Base Unit and computer hardware, only specified USB hubs or active USB-repeaters can address the issue - please ask Roche Diagnostics Australia for information. This action has been closed-out on 30/01/2017.

Device

USB Communication Data Loss – Handheld Base Unit and Accu-Chek Inform II Base Unit
  • Modelo / Serial
    USB Communication Data Loss – Handheld Base Unit and Accu-Chek Inform II Base UnitVarious affected productsARTG number: 202785 (cobas h 232 POC system)ARTG number:197926 (CoaguChek Professional meters)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited