Events

Alerta De Seguridad para ADVIA Chemistry Hemoglobin A1c_3 - Model Kit of 2x80 tests: agglutinator / Reagent - Registration nº 10345161848. Lots: Kit 2X80 tests lot 230; Kit 4X200 tests lot 230 and 231

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..

¿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
    1700
  • Fecha
    2015-10-21
  • 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
    Positive BIAS in% HbA1c may be considered clinically significant and relevant to HbA1c values ​​and may result in a modification in therapy for hyperglycemia. Modification in the therapy of hyperglycemia may increase the risk of hypoglycemia occurring, which should be observed through monitoring of personal glucose and / or patient symptoms. .
  • Causa
    Siemens healthcare confirmed that batches of the hemoglobin a1c_3 / a1c_3m reagent used in the advia chemistry 1200, 1800, 2400 and xpt systems demonstrated an increase in the occurrence of bias positive in% hba1c determination. internal investigations carried out by siemens have demonstrated that batches of reagents 230 and 231 may exhibit an average positive bias of 0.6% for hba1c, ranging from -0.1% to 1.1% in hba1c units.
  • Acción
    Siemens Healthcare recommends the following actions: - Discontinue use and discard batches of reagents identified in this Field Action; - Keep the Portuguese Letter CHC 15-19 (Alert Message) in your laboratory records for any future consultations.

Device

ADVIA Chemistry Hemoglobin A1c_3 - Model Kit of 2x80 tests: agglutinator / Reagent - Registration...

Manufacturer

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