Events

Retiro De Equipo (Recall) de Medtronic MiniMed Infusion Sets MiniMed Quick-set MiniMed mio MiniMed Silhouette MiniMed Sure-T

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia Pty Ltd.

¿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
    RC-2017-RN-01182-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-11
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01182-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. over-delivery of insulin can cause hypoglycaemia and in extreme cases, death. medtronic has received reports of hypoglycaemia requiring medical intervention potentially related to this issue. out of the millions of infusion sets sold each year, the reported incident rate requiring medical assistance related to this issue is less than 0.00005%. there have been no reports of death related to this issue.An investigation by medtronic has shown this issue can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. a membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on the top of the reservoir or inside the tubing connector which then could prevent the infusion set from working properly.
  • Acción
    For patients: 1. Users and HCPs with affected lot numbers (as confirmed with Medtronic using the dedicated webpage https://checklots.medtronicdiabetes.com or Global Help Line 1800 777 808) are to cease using the sets and, in the absence of unaffected alternatives, follow the steps contained in the supplied letter. Medtronic will replace the affected sets free of charge. 2. Cut out the bar codes on the boxes of recalled infusion sets (as per supplied picture) and return the bar codes in the reply paid envelopes that will be sent out with the new infusion sets. 3. Users are to discard, not return, the affected sets. 4. Customers are also requested to complete and sign the supplied Acknowledgment Form, and return as directed to Medtronic Australasia. For further information, please see https://www.tga.gov.au/alert/medtronic-minimed-infusion-sets

Device

Medtronic MiniMed Infusion Sets MiniMed Quick-set MiniMed mio MiniMed Silhouette MiniMed Sure-T
  • Modelo / Serial
    Medtronic MiniMed Infusion SetsMiniMed Quick-setMiniMed mioMiniMed SilhouetteMiniMed Sure-TARTG Number: 119216
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA