Alerta De Seguridad para Trade name: Diamed - Id-Diapanel. Technical Name: Immunohematology - Reagents of Enzyme Treated Cells / Hemacices. ANVISA registration number: 80004040131. Class of risk: IV. Model affected: 00 000 000 0041 14. Serial numbers affected: Kit lot: 45161.94.1 (Kit: ID-DiaPanel). Lot of the red blood cell reagent ID-DiaPanel 5: 06211.94.1 (red blood cell reagent in which the problem was identified) .. Number of the red cells reagent bottles ID-DiaPanel 5 Lot 06211.94.1 where the problem was identified: 000007, 00009, 000010, 000013, 000014, and 000018. The vials whose serial numbers are 000015, 000020 and 000030, the respective Customers did not test the antigens and the substitution was performed as a containment measure.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Diamed Latino América 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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    * Check the serial number of the kit reagent vial id-diapanel 5 kit 45161.94.1 expired 08/14/2017 (information printed on the bottle label) * If the vial is numbered up to 0000030, test the antigens "f and b" and "m" antigens. If no antigen "fyb" and "m" is present, a new vial of the idia diaphragm reagent 5 will be shipped 06211.94.2 due 08/14/2017 to replace the one initially sent. antigens "fyb" and "m", use the product normally * Other reactive red cells that make up the kit id-diapanel lot 45161.94.1 are in accordance with the specifications of the product and can be used normally If you want to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 07/26/2017 - Date of notification notice to Anvisa: 03/08/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    On the basis of customer complaint, quality control identified a decrease in reactivity for the "fyb" and "m" antigens in the idia diaphragm 5 (lot 06211.94.1) component of the end product id-diapanel "(lot 45161.94.1 due 08/14/2017). during the investigations, it was identified that such decrease of reactivity for the "fyb" and "m" antigen occurred randomly in the bottled bottles at the beginning of the packaging process. future reference samples of the bulk (formulation from which the product is packaged) and samples taken along the package did not present the problem.
  • Acción
    Field Action Code AC 2017/02 triggered under the responsibility of the company Diamed Latino America SA that will replace the test-blood5 whose numbers are up to 000030.