Events

Retiro De Equipo (Recall) de Roche ACCUCHEK Spirit Plus insulin pump

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Disetronic Medical Systems, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    51695
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1646-2009
  • Fecha de inicio del evento
    2009-04-30
  • Fecha de publicación del evento
    2009-05-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81008
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Insulin Infusion Pump - Product Code LZG
  • Causa
    The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate.
  • Acción
    The firm issued a press release on 4/30/09 and sent letters with attached Urgent Medical Device Recall (Field Corrective Action) notification dated 5/4/09 to distributors, health care providers and users. Disetronic will replace pumps within the affected serial numbers (SN02119552 to SN10006093) that have intermittent or complete loss of function of the up and/or down button promptly upon contact from the customer with a new pump that is not affected by the potential button failure. For pumps within the affected serial numbers (SN02119552 to SN10006093) which are functioning properly, no replacement is available/possible at this time. Disetronic will gradually phase in replacement pumps for the remaining pumps within the affected range, as they become available. Customers are to complete the enclosed Customer Reply Card to acknowledge receipt of the notification. On 5/17/11, after being notified of the recall's ineffectiveness (in that only 40% of the pumps had been replaced), the firm re-issued recall notification letters including the aforementioned information to their consignees.

Device

Roche ACCUCHEK Spirit Plus insulin pump
  • Modelo / Serial
    All units with serial numbers SN02119552 thru SN10006093.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and Canada.
  • Descripción del producto
    Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001.
  • Manufacturer
    Disetronic Medical Systems, Inc.

Manufacturer

Disetronic Medical Systems, Inc.
  • Dirección del fabricante
    Disetronic Medical Systems, Inc., 11800 Exit 5 Pkwy Ste 120, Fishers IN 46037-7989
  • Source
    USFDA