Events

Alerta De Seguridad para Vancomycin

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Roche Diagnostics.

¿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
  • Fecha
    2016-05-31
  • Fecha de publicación del evento
    2016-05-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160531b.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: roche diagnostics vancomycin medical device manufacturer, roche diagnostics, has issued a medical device safety alert concerning the following products: 04491050190 online tdm vancomycin 100 tests 05108420190 online tdm vancomycin 200 tests 04642490190 hitachi vancomycin (p) 04642481190 hitachi vancomycin (p) the ifus (instructions for use) for vancomycin on cobas c 311/501/502 and modular analytics p-module state an incorrect method comparison against cobas integra 800. since the cobas integra reagent is not yet adapted, results generated with cobas integra are still up to 20 % higher than with cobas c or modular analytics p-module. the method comparison shown may lead to the assumption that both methods are comparable and may affect the interpretation of vancomycin test results. the issue can potentially lead to misinterpretation of results. in case that the first result has been generated with integra and the following result using cobas/hitachi assay, the difference between assays might be interpreted as decrease in vancomycin concentration which can further trigger the increase in the dosage. in this case, a medical risk of toxic effects due to the increased vancomycin dosage cannot be excluded. incorrect method comparison will be deleted from the ifus. affected users are instructed to ignore the wrong method comparison in the ifus. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 may 2016.

Device

Vancomycin
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Roche Diagnostics Vancomycin
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics