Events

Alerta De Seguridad para ARCHITECT ICT Module

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

¿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
    2018-09-04
  • Fecha de publicación del evento
    2018-09-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180904a.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: abbott architect ict module medical device manufacturer, abbott laboratory, has issued a medical device safety alert concerning its architect ict module. the affected devices are identified as follow: list number: 09d28-03; lot number: 180326; expiration date: 26 december 2018; udi: (01)00380740019327(17)181226(10)180326(21)180326301 through (01)00380740019327(17)181226(10)180326(21)180326399. the manufacturer has received customer complaints regarding higher than expected serum or plasma chloride results when using the affected products. based on an analysis of quality control (qc) data from existing customers, the results generated using this lot number may be up to 6.2% higher than expected. the customer qc data do not indicate an issue with urine chloride results. according to the manufacturer, the issue only impacts the chloride electrode element of the ict module, potassium and sodium results are not impacted. there is the potential to generate falsely elevated serum or plasma chloride results when using the affected products. there is also the potential to delay the reporting of chloride ict results due to the time required for the user to attempt troubleshooting of the issue with falsely elevated serum chloride qc results. the affected users are advised to immediately discontinue the use of the affected products. they should destroy any remaining inventory of the impacted lot number according to their laboratory procedures. they also should discuss with their medical director and follow their laboratory protocol regarding the need for reviewing previously reported patient results. product replacement is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 4 september 2018.

Device

ARCHITECT ICT Module
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott ARCHITECT ICT Module
  • Manufacturer
    Abbott Laboratory

Manufacturer

Abbott Laboratory
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH