Alerta De Seguridad para PSA IMMULITE / IMMULITE 1000 and PSA IMMULITE 2000 - ANVISA Registry No. 10345160687 and 10345160915

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 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
    1284
  • Fecha
    2013-08-12
  • País del evento
  • Fuente del evento
    ANVISA
  • 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
    A positive bias in PSA results may impact clinical interpretations of test results. In cases where true values ​​are close to cut, bias may increase the likelihood of a decision to initiate complementary diagnostic tests (including prostate biopsy). The risk of unnecessary biopsy is mitigated by the fact that the physician / patient decision for prostate biopsy is based on a number of additional factors for the PSA outcome, including the patient's age, findings in digital rectal examinations, clinical signs and symptoms or comorbidities such as inflammation or prostate infection. Total PSA is used in conjunction with a digital rectal examination to assist in determining if the patient is at risk for prostate cancer. The combination of the test result and an abnormal DRE may lead to a prostate biopsy. Sequential testing and a substantial change in results between tests may also raise the suspicion that the patient may be at risk for prostate cancer. When used in conjunction with the IMMULITE free PSA assay, bias would also result in a potentially lower than expected rate. Decreased indices are associated with increased risk of prostate cancer and could probably influence biopsy decisions. Findings in the biopsy are independent of the positive bias and health risk does not extend beyond biopsy and anxiety to the patient. The frequency of events of an increased value above the reference range of 4 is estimated at 5% (source not found) and having a positive DRE is estimated at 5% of the screened population equaling 2.5 x 10-3 in the worst case, very probably one tenth of this if the doctor questions the result. The health risk of an unnecessary biopsy is low.
  • Causa
    Siemens healthcare diagnostics has confirmed an overall mean positive bias of approximately 20% - 23% across the entire test range compared to who 96/670 with the immulite assays. this positive bias is observed in patient values ​​and controls of siemens tumor marker (tmco). the positive bias reported begins in the kits lots launched in february 2012: • immulite / immulite 1000 kit lkps of lot 422 and lkpts of lot d103. • immulite 2000 / immulite 2000 xpi kit l2kps from lot 377 and l2kpts from lot d104.
  • Acción
    Discontinue use and segregate the remaining kits from your inventory with a view to returning these products to Siemens. If you have purchased the affected product from an authorized distributor, please return the product to your dealer. Siemens will replace any unused inventory of affected lots at no cost. Please contact your local Siemens representative for assistance in determining the appropriate solution for your laboratory's PSA testing. In addition, please proceed as follows: • Complete and return the Effectiveness Check Form • Forward this letter to whom you may have distributed these products. If you have questions or need additional information, please contact the Customer Support Center (0800-129-633).

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA