Events

Alerta De Seguridad para Trade name: ADVIA Chemistry Triglicerides Concentrate TRIG_c Technical name: PROGESTERONE Registration number ANVISA: 10345160327; 10345161844; 10345160654 Hazard Class: II Affected Model: 50 determinations; 250 determinations; kit for 100 tests; kit for 200 tests; kit for 600 tests. Affected lot / series numbers: 0

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; 1) Siemens Healthcare Diagnostics Inc. 2) Siemens Healthcare Diagnostics Products Ltd..

¿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
    2100
  • Fecha
    2017-01-19
  • 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
    These trials should not be used to report results to patients who are using DHEA supplements. For patients using DHEA supplements, an alternative method should be used to measure Progesterone concentrations, such as Liquid Chromatography - Mass Spectroscopy (LCMS), which is not expected to demonstrate cross-reaction with DHEA-S. However, Siemens Progesterone assays can continue to be used to report results from patients not using DHEA supplements.
  • Causa
    Siemens healthcare diagnostics has confirmed that the presence of dhea-s (a dhea metabolite, a steroid hormone that is used as part of in vitro fertilization (ivf) protocols to increase the ovarian response and in treatment results) causes falsely elevated results for the progesterone trials listed in the "product data" annex, close to the clinically important decision level of progesterone.
  • Acción
    Field Action Code CC 17-06 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send letter to the client.

Device

Trade name: ADVIA Chemistry Triglicerides Concentrate TRIG_c Technical name: PROGESTERONE Registr...

Manufacturer

Siemens Healthcare Diagnósticos S.A; 1) Siemens Healthcare Diagnostics Inc. 2) Siemens Healthcare...
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA