Events

Retiro De Equipo (Recall) de ADVIA Chemistry XPT Systems with software version 1.0.3. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare 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-2015-RN-01049-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-28
  • 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-2015-RN-01049-1
  • 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
    Siemens healthcare diagnostics has identified multiple issues with the advia chemistry xpt systems with software version 1.0.3 that may affect the day to day behaviour and/or workflow of the system as follows:auto start-up failingcalibration interval resets when a reagent blank (rbl) is runcontrol definition screen assumes that the range is defined is 2 sd (standard deviation)laboratory information system (lis) communication / laboratory automation (las) issueprinter driver resetsise calibration ranges are too conservative for urine sodium (na)archiving and deletion may failworkstation services may restartwith the alerts generated by the instrument for the scenarios impacting samples, the operator will be aware that a sample may not have been processed and can take action. calibration and control issues are detectable through normal laboratory monitoring practices.
  • Acción
    All the issues above except (Issue: Workstation services may restart) are corrected in software version 1.1 which is now available for installation on affected systems. The temporary actions defined in the customer letter should be undertaken until the affected systems have been upgraded to software version 1.1. The remaining issue will be corrected in a future software version.

Device

ADVIA Chemistry XPT Systems with software version 1.0.3. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ADVIA Chemistry XPT Systems with software version 1.0.3. An in vitro diagnostic medical device (IVD)Siemens Material Number (SMN): 10723034ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA