Events

Retiro De Equipo (Recall) de VITEK 2 system version 7.01. 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 Biomerieux 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-2015-RN-00132-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-02-18
  • 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-00132-1
  • 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
    Vitek 2 software ver. 7.01 introduced a feature (enable > convention for highest reportable mic) which can be used to modify the ast (antimicrobial susceptibility testing) reporting convention when an ast result is within the highest reportable mic range. advanced expert system (aes) parameter sets are configurable in the vitek 2 software to allow users to select mic breakpoint interpretation.The enable > convention for highest reportable minimum inhibitory concentration (mic) configuration option modifies the highest reportable mic value for each specific antimicrobial to half its doubling dilution and displays the value with a > (greater than) symbol. for example, =32 (highest reportable mic) would be modified to >16 which are equivalent for mic testing.Patient isolates function as intended; however, the software does not recognise the two values (e.G. =32 vs. >16) as equivalent, and incorrectly flags the modified value as a deviation.
  • Acción
    Biomeriux is requesting their customers that in the event of a QC deviation for one or more of the ATCC strains and antibiotics indicated, to compare the reported MIC value to the expected MIC value. If the values are equivalent, the deviation is subject to the software discrepancy and can be ignored. This issue will be corrected in software release 8.01 This action has been closed-out on 09/08/2016.

Device

VITEK 2 system version 7.01. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITEK 2 system version 7.01. An in vitro diagnostic medical device (IVD)Catalogue number: 416381ARTG: Transitioning
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd