Events

Rappel de Medtronic Minimed 640G Infusion Pump used in clinical trials

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00061-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-01-29
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00061-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Medtronic has implemented an amendment to the pump user guide for medtronic minimed 640g insulin pumps. the change involves the bolus delivery accuracy listed in the pump user guide for very small bolus amounts (less than 0.1 u). delivery accuracy for bolus volumes < 0.1 unit is now updated to ±20%, from ±5%. the delivery accuracy for bolus volumes = 0.1 unit remains ±5%, as does the delivery accuracy for basal delivery.Medtronic considers that there is not likely to be any clinical risk associated with this change in delivery accuracy.
  • Action
    An update to the published Instructions for Use (IFU) regarding the stated resolution of the device at a dose of <0.1 Unit is to be circulated to customers. This action has been closed-out on 08/08/2016.

Device

Medtronic Minimed 640G Infusion Pump used in clinical trials
  • Modèle / numéro de série
    Medtronic Minimed 640G Infusion Pump used in clinical trialsModel Numbers: MMT-1511 & MMT-1512
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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