Events

Alerta De Seguridad para ACCU-CHEK® Hair Glucose Monitor

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Roche Diagnóstica Brasil Ltda.

¿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
    848
  • Fecha
    2006-12-13
  • 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
    Maltose, Xylose and Galactose are glucose-like sugars that are found as components in some substances, or arise as the product of the metabolism of other substances. These substances, seldom used in our country, are: Octagam® - Immunoglobulin, Gamimune® N-immunoglobulin, WinRho®-immunoglobulin, Vaccinia Immune Globulin (human) -immunoglobulin, D-Xylose-malabsorption test, Extraneal (Icodextrn ) - dialysis solution. Other substances that affect the blood glucose reading, when they are beyond the therapeutic and physiological concentrations are: acetaminophen, galactose and uric acid.
  • Causa
    Note: this information is only to reinforce the instructions for use contained in the package insert since 1998. information only for use in the hospital.///////////////////// ////// potential interferences with drugs that induce false or elevated or inaccurate reading of blood glucose through accu-chek® monitors that use the gdh-pqq (glucose dehydrogenase pyrroloquinololinequinase) methodology, since it recognizes maltose, galactose and xylose as being glucose. products that use the gdh-pqq methodology, object of this security alert, are: accu-chek advantage - registry nº10287410170; accu-chek complete - registration no. 10287410170; accu-chek inform - registration nº 10287410278.
  • Acción
    Roche Diagnostica Brasil Ltda informs that this information is contained in the product manual and provides complementary information on this subject, in the following links (copy) links: http: //www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/848_avalia. pdf http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/848_%20evaluations_report.pdf http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/848_maltose.pdf http: // www .anvisa.gov.br / tecnovigilancia / alerts / annexos_2006 / 848_perguntas_frequentes.pdf http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/848_relatorio.pdf http://www.anvisa.gov.br/tecnovigilancia /alertas/anexos_2006/848_recall.pdf http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/848_superfast.pdf

Device

ACCU-CHEK® Hair Glucose Monitor

Manufacturer

Roche Diagnóstica Brasil Ltda
  • Source
    ANVSANVISA