Events

Alerta De Seguridad para GLYCADA HEMOGLOBIN. Anvisa Registry n ° 10009010016. Lots under risk: 3101, 3201 and 3301.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por LABTEST DIAGNÓSTICA 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
    1356
  • Fecha
    2014-02-19
  • 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
    According to LABTEST, considering the use of the product as proposed in its instructions for use, the test result adds information about the glycemic control status of the patient and is not directly associated with the definition of drug therapy, thus representing a potential very low damage to the patient. However, the company advises its clients to consider the need to review the results of the patients for whom they have used the affected batches and, if necessary, to provide this information to the Laboratory Technician and to the physician or healthcare professional requesting the test , so that appropriate actions can be taken. Check the company's alert message to the end customer at http://portal.anvisa.gov.br/wps/wcm/connect/75a7ae8042fd73d588dcaf348b3626d1/Communicado+Cliente.pdf?MOD=AJPERES. Check the company's alert message to resellers at http://portal.anvisa.gov.br/wps/wcm/connect/6a2ea48042fd742288e6af348b3626d1/Communicado+Revenda.pdf?MOD=AJPERES.
  • Causa
    Plots 3101, 3201 and 3301 of the product glycated hemoglobin present results with a negative deviation in the determination of total glycated hemoglobin. the results may be up to 40% lower than the true value in quality control samples and also in patient samples.
  • Acción
    Check your inventory for products at risk and segregate them immediately, identifying them to avoid inadvertent use. The products must be returned to the manufacturer. Consider the need to review the results of the patients for whom they have used the affected lots and, if necessary, provide this information to the Laboratory Technical Manager and the physician or health care professional requesting the test so that appropriate action can be taken.

Device

GLYCADA HEMOGLOBIN. Anvisa Registry n ° 10009010016. Lots under risk: 3101, 3201 and 3301.

Manufacturer

LABTEST DIAGNÓSTICA S.A.