Events

Alerta De Seguridad para DxH 500

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

¿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
    2016-03-09
  • Fecha de publicación del evento
    2016-03-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160309a.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: beckman coulter dxh 500 medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its dxh 500 (part number: b40601, software versions 1.0.0 and 1.0.1). the manufacturer is notifying users regarding an error in the result abnormal flags field transmitted from the dxh 500 to the laboratory information system (lis). test values are not affected. according to the manufacturer, the logic for the “a” code used in the result abnormal flags field is reversed for all test parameters. this letter does not apply if the user’s laboratory is not transmitting results to an lis or if the lis driver does not use the result abnormal flags field. the test results and flags generated by the instrument are correct and are not affected by this issue. the definitive messages, system messages, parameter flags and codes, reference intervals and action limit flags are displayed, printed and transmitted to the lis correctly. however, there is an additional flag, result abnormal flag, which is only transmitted to the lis that is incorrect. if the lis is using the result abnormal flags field, the lis may incorrectly interpret results. specifically, correct normal values may be erroneously flagged as abnormal and correct yet abnormal results may be missing the abnormal flag. this issue will be corrected in a future software release. 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 9 march 2016.

Device

DxH 500
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Beckman Coulter DxH 500
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter