Alerta De Seguridad para cobas e 411 analyzer

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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 cobas e 411 analyzer medical device manufacturer, roche diagnostics, has issued a medical device safety alert concerning its cobas e 411 analyzer. the details of the affected products are as follows: product names: 1) cobas e 411 analyzer (disk system); 2) cobas e 411 analyzer (rack system) catalogue numbers: 1) 04775279001; 2) 04775201001 all software versions the manufacturer informs customers that in very rare cases a software (sw) malfunction in the sample&control datafile can occur which may lead to a potential data mismatch. this sw malfunction only occurs: when the “sample data clear” function is not performed daily as indicated in the operator’s manual, and when the sample&control datafile of the cobas e 411 analyzer is filled with > 2000 records. according to the manufacturer , all tests that are run on cobas e 411 are potentially affected whereas the impact of the data mismatch cannot be predicted. the manufacturer has received a total of four customer complaints for this issue. the manufacturer advises customers to perform the following actions: perform a “sample data clear” daily until the new sw has been installed. as sample data clear deletes all sample records and moves qc data to the qc view. it is recommended to perform the backup procedure on a regular basis, depending on data volume and the regulations at customer site. if the system is connected to a host, make sure that all data has been uploaded before performing a sample data clear. when the new sw version is available it will be installed as a mandatory update to the system. 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 29 june 2017.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Roche Diagnostics cobas e 411 analyzer
  • Manufacturer