Events

Alerta De Seguridad para Trade Name: ADVIA Hematology System; 10345161959; Risk class I; Affected Model - ADVIA 560 Hematology System; Number of series affected: S020202, S020201, S020200, S020197.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1867
  • Fecha
    2016-04-04
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
  • Causa
    Siemens healthcare has identified that equipment with software version 1.4.2133 does not indicate the following flags: warning flag for low sample volumes (flag w) and morphology flags indicating the presence of immature granulocytes (g) and atypical lymphocytes (l). if the user uses the device with the affected software version, the results may be lower than expected.
  • Acción
    Action code HI 16-01. Initiated by Siemens, it is sent a Letter to the Customer prepared in March 2016 with risk classification III (situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences). Recommendation to users and patients: To ensure that the patient sample quantity is sufficient to perform the assay, it is recommended to follow the requirements described in the ADVIA 560 Hematology System Operator's Manual. Siemens recommends a review of the abnormal results for white cells , confirming them with the manual differential when necessary.

Device

Trade Name: ADVIA Hematology System; 10345161959; Risk class I; Affected Model - ADVIA 560 Hemato...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA