Events

Alerta De Seguridad para LifeScan OneTouch Ultra blood glucose meters

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

¿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
    2006-12-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20061219.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
    Press release
  • Causa
    Dh closely monitoring safety of lifescan blood glucose meter the department of health (dh) was notified by johnson & johnson (hong kong) limited that the company was following up whether the lifescan onetouch ultra blood glucose meters supplied to hong kong were of the same design and software as those available in united kingdom. a dh spokesman said that the unit of measurement of some meters of this model in united kingdom might change from mmol/l to mg/dl if the meter was dropped or if the battery was changed when the meter was switched on. the spokesman said, "as a precautionary measure, users of any brands of blood glucose meters should always check and ensure that the unit of measurement is in mmol/l in every test. if the unit of measurement is in mg/dl, they should immediately contact their suppliers." "members of the public are advised to follow strictly instructions in the manual when using blood glucose meters." the spokesman said that dh had informed the public and private hospitals, nursing homes, medical professional associations, and diabetes patient support groups about this safety issue. dh has not received any report of adverse events related to the unit of measurement issue, he added. relevant information has also been posted on the mdco website http://www.Mdco.Gov.Hk/english/recalls/recalls.Html . ends/tuesday, december 19, 2006 nnnn.

Device

LifeScan OneTouch Ultra blood glucose meters
  • Modelo / Serial
  • Descripción del producto
    Press release: DH Closely Monitoring Safety of Lifescan Blood Glucose Meter
  • Manufacturer
    Johnson & Johnson

Manufacturer

Johnson & Johnson