Events

Alerta De Seguridad para Accu-Chek Inform II Base Unit and Handheld Base Unit, registry 10287410863, hazard class II, batches affected: 05802151 to 05205301 and 05809021 to 05205311.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH.

¿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
    1803
  • Fecha
    2015-01-22
  • 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
    Complaints were reported to the Accu-Chek Inform II system when connected to the TI1000 cobas using the USB connectivity option. No case was reported for Ethernet or WLAN option. The affected BU / HBU are those with 3 years of use or the oldest ones. #### UPDATED ON 11/21/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Causa
    Potential risk of data loss during usb communication between the meter and the data management system. some accu-chek infrm ii base units (bu) and handheld base units (hbu) used in coaguchek professional meters and cobas h232 meters can produce physical transmission errors in the form of data loss in usb communication between the measured and the system of data management. this happens in rare cases of data transmission with pocti-a communication via a usb connection to a pc.
  • Acción
    Customer communication and software update. Action code: SBN_RPD_2015_020. The company advises not to use the USB connectivity option without other precautions because the data loss produces invalid data. The manufacturer is developing a new version of the "Roche BU / HBU Control Panel" to improve flaws. The new version is planned for the first quarter of 2016. Workarounds to avoid the problem HW: change connectivity method or request from Roche a USB hub or active USB repeater to improve the signal.

Device

Accu-Chek Inform II Base Unit and Handheld Base Unit, registry 10287410863, hazard class II, batc...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH