Events

Retiro De Equipo (Recall) de ONLINE TDM Gentamicin. An in vitro diagnostic medical device (IVD)cobas c 501/502 modules

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-2017-RN-00374-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-20
  • 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-2017-RN-00374-1
  • 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
    On 30 may 2016, customers using the online tdm gentamicin (gent2) assays were advised to stop using certain lots of the assay due to reports of increased recovery in patient results. (customers would also have received the customer bulletin reference number: cc16-029, notifying that the online tdm gentamicin assay was once again available for use following the implementation of a mandatory instrument factor (a = 0.8) and re-assignment of the tdm control set values.)several reports have since been received that after the instrument factor (if) was implemented, decreased recovery of patient results were observed. further internal investigations suggested that the if of 0.8 is incorrect, leading to decreased recovery of gentamicin results. this may lead to over dosage, which would cause potential toxic concentrations in patients.
  • Acción
    Roche Diagnostics Australia (Roche) is requesting users NOT to implement the IF of 0.8 on cobas c 501/502/701/702 modules. Users are further requested to reset or leave the IF at1.0 and set the technical limit back to the original values. Roche has released re-assigned control values (which have to be implemented) via updated e-packages and would like to advise users that work a on a long term solution to correct the issue is still underway. Users are requested to follow further instructions as detailed in their recall notification letter.

Device

ONLINE TDM Gentamicin. An in vitro diagnostic medical device (IVD)cobas c 501/502 modules
  • Modelo / Serial
    ONLINE TDM Gentamicin. An in vitro diagnostic medical device (IVD)cobas c 501/502 modulesMaterial Number: 04490843190cobas c 701/702 modulesMaterial Number: 05841291190ARTG Number: 174910
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited