Events

Alerta De Seguridad para AutoMate 2500 Family systems with Sorting-Drive software upgraded from version 4.1.2 to 4.2

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
    2016-05-31
  • 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_20160531a.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 automate 2500 family systems with sorting-drive software upgraded from version 4.1.2 to 4.2 medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its automate 2500 family systems with sorting-drive software upgraded from version 4.1.2 to 4.2. the manufacturer has identified a software error with sorting-drive version 4.2. this issue only impacts customers that have upgraded from sorting-drive software version 4.1.2 to version 4.2. the software error prevents the ability of the sorting-drive to process updates to original test orders received via the laboratory information system (lis). updates to original test orders consist of the following three (3) actions: an already completed test is rerun/repeated an additional test is added to an existing test order a test is removed or deleted from an existing test order any test updates to an original order will not be processed. the sorting-drive software provides no notification that the test updates were not processed. this may cause a delay in results for any tests which are requested after the original test order (i.E. reruns or added tests). any updates to original test orders (reruns or added tests) need to be processed manually, as described below: monitor the lis to identify test orders which have not been processed in the normal timeframe. identify which of these were requested after the original test order (i.E., reruns or added tests). locate the associated samples and load these directly onto the analyzer for processing, bypassing the automate 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 31 may 2016.

Device

AutoMate 2500 Family systems with Sorting-Drive software upgraded from version 4.1.2 to 4.2
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Beckman Coulter AutoMate 2500 Family systems with Sorting-Drive software upgraded from version 4.1.2 to 4.2
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter