Events

Retiro De Equipo (Recall) de Device Recall T:slim Insulin Infusion 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 Tandem Diabetes Care 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
    67264
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0827-2014
  • Fecha de inicio del evento
    2014-01-10
  • Fecha de publicación del evento
    2014-02-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125111
  • 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
    Pump, infusion, insulin - Product Code LZG
  • Causa
    Specific lots of insulin cartridges that are used with the t:slim insulin pump may be at risk for leaking. a cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event.
  • Acción
    Tandem Diabetes Care sent an Urgent Medical Device Voluntary Recall letter dated January 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check the lot numbers of their cartridge supply against the llist of affected lot numbers. Do Not use any cartridges from the lots affected by this recall. If customers don't have useable cartridges, discontinue using the pump and revert to their backup plan until new supplies arrive. Customers were instructed to call Tandem Technical Support at 1-877-801-6901 to receive replacement cartridges at no charge. Customers were asked to return the enclosed return response form via email, fax, or mail. UPDATED: Tandem Diabetes Care expanded the recall om January 20, 2014. Tandem Diabetes Care¿, Inc. (NASDAQ: TNDM), or Tandem, today announced that it is expanding a voluntary recall of specific lots of insulin cartridges that are used with the t:slim¿ Insulin Pump. For questions regarding this recall calll 858-366-6900, ext 6963.

Device

Device Recall T:slim Insulin Infusion Pump
  • Modelo / Serial
    Lot Numbers: M000857, M001414, M001454, M001963, M002028, M000869, M001415, M001455, M001964, M002029, M001344, M001416, M001456, M001973, M002030, M001345, M001417, M001457, M001974, M002082, M001346, M001420, M001458, M001979, M002083, M001347, M001421, M001459, M001980, M002096, M001389, M001422, M001460, M001987, M002097, M001390, M001423, M001528, M001988, M002099, M001391, M001451, M001529, M001990, M002100, M001392, M001452, M001530, M001991, M002119, M001393, M001453, M001532, M002027, M002120.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationwide)
  • Descripción del producto
    T:slim Insulin Delivery System || Insulin Infusion Pump
  • Manufacturer
    Tandem Diabetes Care Inc

Manufacturer

Tandem Diabetes Care Inc
  • Dirección del fabricante
    Tandem Diabetes Care Inc, 11045 Roselle St Ste 200, San Diego CA 92121-1231
  • Empresa matriz del fabricante (2017)
    Tandem Diabetes Care Inc
  • Source
    USFDA