Events

Alerta De Seguridad para Trade name: CAL IRI CALIBRATOR ADVIA CENTAUR ACS 180 SYSTEMS; ADVIA CENTAUR IRI Technical name: CAL IRI CALIBRATOR ADVIA CENTAUR ACS 180 SYSTEMS; ADVIA CENTAUR IRI ANVISA registration number: 10345160303; 10345161868 Affected Model: MAMMOMAT Inspiration

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; Siemens Healthcare Diagnostics Inc.

¿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
    2281
  • Fecha
    2017-04-28
  • 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
    Siemens does not recommend a review of previously generated results. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Causa
    Siemens healthcare diagnostics is making this notice available to communicate the restoration of the insulin (iri) trial advia centaur systems to the world health organization (who) 1st irp standard 66/304. siemens internal investigation has identified that the current batches of insulin systems advia centaur recover approximately 40% higher than the first world health organization (who) irp 66/304 standardization based on slope values. the slope value was observed at 1.40 on advia centaur xp and 1.42 on advia centaur cp. siemens confirmed that assay reportable range, reference range, precision, analytical sensitivity, accuracy, pro-zone effect and linearity were not impacted by this problem and continue to achieve the performance characteristics mentioned in the instruction of use (ifu). the investigations also concluded that the root cause of this problem is related to the raw material used during the production of the iri calibrators. this problem has been corrected and the standardization to the 1st irp 66/304 who has been restored starting with the iri advia centaur primer packs finished in 201 when paired with batches of iri caliper finished in 02, which will be available in may 2017.
  • Acción
    Field Action Code CC 17-10 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Trade name: CAL IRI CALIBRATOR ADVIA CENTAUR ACS 180 SYSTEMS; ADVIA CENTAUR IRI Technical name: C...

Manufacturer

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