Events

Notificaciones De Seguridad De Campo acerca de ADVIA Chemistry System

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por SIEMENS HEALTHCARE DIAGNOSTICS INC..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2013-09-17
  • Fecha de publicación del evento
    2013-04-10
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2013/10/04/vazno-obavestenje-o-medicinskom-sredstvu-advia-chemistry-system-model-1200-1800-2400-biohemijski-analizator/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    Siemens healthcare diagnostics manufactures field correction for advia 1200, 1650, 1800 and 2400 chemistry systems. the manufacturer has determined that these calculation test systems produce unmarked results when the results of the individual tests used in the calculation have labels. in cases where the marks suppress the numerical result, no calculation will be made. if a numerical result is generated with the tag, the calculation test will be issued without the tag. the results of the individual tests used to calculate the most common test ratios (eg anion gap, a / g ratio, osmolality and estimated ionized calcium) are of clinical significance and are commonly reviewed and released together with the result of the calculated ratio. however, the% hba1c_3 method can be set to produce only a score for the relationship, which means that if the tests included in the calculation are labeled, they will not be displayed on the end result, potentially leading to an inappropriate assessment of the patient's glucose control.

Device

ADVIA Chemistry System

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS INC.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ALIMSA