Events

Alerta De Seguridad para Accu-Chek Compact test strips and Accu-Chek Mobile tests

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

¿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
    2014-04-10
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140410.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
    Safety alert over certain brands of roche diabetes care blood glucose test strips and blood glucose monitoring systems the department of health (dh) today (april 10) drew public attention to a safety alert issued by roche diagnostics (hong kong) limited concerning two glucose test strips namely accu-chek compact test strips and accu-chek mobile tests, respectively compatible with its home blood glucose monitoring systems accu-chek compactplus meter and accu-chek mobile meter, manufactured by roche diabetes care. according to the manufacturer, the test strips may lead to erroneously lowered blood glucose readings in patients undergoing ceftriaxone therapy, which is administered intravenously or intramuscularly. this limitation is not described in the product labelling. a spokesman for the dh said that ceftriaxone is a type of antibiotic used for treating a variety of infections such as respiratory infections or lower urinary tract infections. patients with diabetes who are receiving this specific therapy should stop using the affected blood glucose monitoring systems and contact their attending doctors. the spokesman explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycemia. "the dh's enquiry with the local supplier reveals that around 2 000 accu-chek compactplus meters and 200 accu-chek mobile meters have been sold locally," the spokesman said. so far, the dh has not received any local report of adverse events arising from use of the affected products. the company has set up a customer service hotline 2485 7512 or 2485 7508 to answer related enquiries. ends.

Device

Accu-Chek Compact test strips and Accu-Chek Mobile tests
  • Modelo / Serial
  • Descripción del producto
    Press release: Safety alert over certain brands of Roche Diabetes Care blood glucose test strips and blood glucose monitoring system
  • Manufacturer
    Roche Diabetes Care

Manufacturer

Roche Diabetes Care