Events

Rappel de CareLink Clinical Therapy Management Software (online diabetes management software)

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-2014-RN-01215-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-14
  • 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-2014-RN-01215-1
  • 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 identified a software error in the carelink clinical therapy management software that might result in an inaccurate display of temp basal time and duration in carelink clinical reports when uploading data from the minimed 640g (models mmt-1511 & mmt-1512) insulin pump. the overall insulin calculation and additional analysis are correct. this issue only affects the graph and the duration data point displayed on carelink reports. this issue does not occur with uploads from other medtronic insulin pump models.The carelink clinical therapy management software is only intended for use in clinical trials and should not be used to provide medical advice to patients or health care professionals.
  • Action
    Medtronic is informing users to not to use the Temp Basal data for clinical consideration when reviewing CareLink Clinical reports. Medtronic’s next version of CareLink Clinical software will resolve this issue and is expected to be available early next year. This action has been closed-out on 11/08/2016.

Device

CareLink Clinical Therapy Management Software (online diabetes management software)
  • Modèle / numéro de série
    CareLink Clinical Therapy Management Software (online diabetes management software)Model Number: MMT-7334ARTG Number: 133091
  • 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