Events

Retiro De Equipo (Recall) de Dimension and Dimension Vista Clinical Chemistry Systems. An in vitro diagnostic medical device (IVD) Assays affected: Triglycerides, Enzymatic Creatinine, Automated HDL Cholesterol, Uric Acid and HDL Cholesterol

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-2016-RN-00350-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-24
  • 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-00350-1
  • 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 become aware of n- acetylcysteine (nac) and metamizole (dipyrone) interference with trinder and trinder-like reaction assays. the trinder reaction is a reaction where hydrogen peroxide is formed and subsequently reacts with a phenol derivative and aminoantipyrine in the presence of peroxidase to form a coloured quinone product. siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving n- acetylcysteine (nac) or metamizole. nac is the accepted antidote for acetaminophen toxicity and is justified in patients at significant risk for hepatotoxicity. the potential exists for reporting falsely depressed results for the assays affected. baseline values before administration of the nac or metamizole therapy would not be affected. it is extremely unlikely these assays would be requested during assessment of acetaminophen overdose and nac treatment.
  • Acción
    Siemens is advising the IFUs for the relevant assays will be updated to indicate that "Venipuncture should occur prior to Metamizole/N-Acetyl Cysteine (NAC) administration due to the potential for falsely depressed results." A review of previously generate results is at the discretion of the Laboratory Director.

Device

Dimension and Dimension Vista Clinical Chemistry Systems. An in vitro diagnostic medical device (...
  • Modelo / Serial
    Dimension and Dimension Vista Clinical Chemistry Systems. An in vitro diagnostic medical device (IVD)Assays affected: Triglycerides, Enzymatic Creatinine, Automated HDL Cholesterol, Uric Acid and HDL CholesterolAll Lot Numbers affectedARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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