Events

Alerta De Seguridad para MediSense Optium / Precision Blood Glucose Test Tapes Monitoring System. Parts No. 99134-15; Lots # 50111, 50113, 50123 Valid until September 30, 2002.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Laboratories MediSense Products; MediSense Contract Mfg.

¿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
  • ID del evento
    394
  • Fecha
    2002-02-25
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The calibrator, the white bar, had incorrect programming for glucose tapes for the tests above. if the affected calibrator is used, the medisense optium / pecision extra blood glucose monitor will prompt the message "cal error", followed by a "313" or "316" error code, and the monitor will not calibrate correctly. the distributor declares that the problem does not influence the customer's safety outcome, and that they are taking appropriate corrective and preventive actions to prevent replication. the distributor initiated a correction by letter dated october 2, 2001.
  • Acción
    Verify that you received the letter dated October 2, 2001, return form, sample letter Abbott MediSense. The distributor declares that it is important to calibrate the monitor with each new test cassette box. Identify and isolate any affected product in your inventory. Use the response form to confirm your current inventory, and return the form to your local Abbott Laboratories representative. Upon receipt of the form, you will receive credit for your inventory and MediSense Accounts, Sales and Services representatives will contact you to arrange for the return of the affected product. Notify any customer who has purchased affected lots with this fix; the Abbott MediSense sample letter can be used for this. For more information, contact your local Abbott MediSense representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

MediSense Optium / Precision Blood Glucose Test Tapes Monitoring System. Parts No. 99134-15; Lots...

Manufacturer

Abbott Laboratories MediSense Products; MediSense Contract Mfg
  • Source
    ANVSANVISA