Events

Alerta De Seguridad para Flex Reagent for HB1C Glycosylated Hemoglobin Dimension, Cartridges (6 x 20) + Calibrators (5 x 2mL) - Registration 10345161815. - Batches GA4266; BA4273; BA4280; BA4287; GA4301; GA4315; GC4322; GA4343; GA4350; GA4357; GA5013; GA5020

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 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
    1446
  • Fecha
    2014-10-21
  • 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
    The monitoring of patients with hyperglycemia depends on diet, lifestyle, glucose concentrations, HBA1c and adjustments of therapies for glycemic control. A positive bias of up to 1.0% [11 mmol / mol] for HbA1c may be considered clinically significant at relevant values ​​and may result in modification of therapy for hyperglycemia. Modification of hyperglycemia therapy may increase the risk of hypoglycaemia, which can be observed by monitoring the patient's blood glucose and / or symptoms.
  • Causa
    Siemens has confirmed that the dimension® hb1c flex® kit for lots ga4266; ba4273; ba4280; ba4287; ga4301; ga4315; gc4322; ga4343; ga4350; ga4357; ga5013 and ga5020 present a mean positive bias of 0.4% [4.4 mmol / mol] in hemoglobin a1c and occasionally 1.0% [11 mmol / mol] in hba1c for patients compared to the national glycohemoglobin standardization program (ngsp). controls can display the same performance. depending on the quality control limits, this problem may not have been detected.
  • Acción
    The company advises customers to discontinue use of the product, segregate any remaining stock from the affected lot of the HB1C Dimension Glycosylated Hemoglobin Flex Reagent in order to return these products to Siemens and to keep the letter with the laboratory records.

Device

Flex Reagent for HB1C Glycosylated Hemoglobin Dimension, Cartridges (6 x 20) + Calibrators (5 x 2...

Manufacturer

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