Alerta De Seguridad para Trade name: VIDAS FSH. Technical Name: Follicle Stimulating Hormone (FSH). ANVISA registration number: 10158120121. Class of risk: II. Model Affected: Not applicable. Serial number affected: 1006006370 and 1005888220

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biomérieux brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; bioMérieux 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
    1. Destroy all impacted batches of VIDAS FSH. 2. Immediately send letters to affected customers. 3. For pre-tests using the impacted batches of VIDAS FSH (batches: 1005888220 and 1006006370), discuss with the technical staff the question of the results previously released with those batches. The results should be reviewed and interpreted in the general clinical context. 4. Complete the knowledge form that accompanies the letter to the clients and return to the 0800 of Biomerieux Brazil or your local representative of the company. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) 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 Additional information: - Date of identification of the problem by the company: 07/03/2018 - Date of notification notice to Anvisa: 03/14/2018 The company that owns the affected product is responsible for contacting its customers in due time. 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
    Customer complaints were recorded due to "invalid calibration" when batches 1005888220 and 1006006370 of the vidas fsh product were used. tests made by the manufacturer have confirmed the decrease of signal s1 for these batches. cross-tests between the strips and the solid phase receptacle (spr) allowed to conclude that the decrease of the signal was related to the strips. the defect was identified by the manufacturer due to complaints received from customers, but was related to all tests performed (calibration and testing with patient samples). theoretical calculation in control 1 (c1) and in a sample allowed to conclude that false results can occur with samples. it was concluded that it could have an impact on patient outcomes. in the market two situations may occur when using vidas fsh with the two batches impacted by this field action: 1- invalid calibration occurs: in this case an error message will appear and the customer will not be able to perform the additional tests with the lots concerned. there will be no risk of false result for the patient. in this context, the risk / impact for the patient may be only the delay in the emission of the results due to invalid calibration. 2 - a valid calibration may also occur: in this case, the risk / impact is the potential for false results for patients. in fact, after a valid calibration, potential false result may occur and will not be identified as such by customers.
  • Acción
    Field Action Code FSCA 3834 triggered under the responsibility of the company Biomérieux brasil Indústria e Comércio de Produtos Laboratoriais Ltda. It will make recollection.