Events

Rappel de MiniMed 640G Insulin Infusion Pump (with software version 2.6)

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-2017-RN-00167-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-02-13
  • 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-2017-RN-00167-1
  • 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
    A software issue affecting some minimed 640g insulin infusion pumps that could prevent the internal battery from charging has been identified. should this issue occur, an alarm will be triggered and users will see a "power error detected" message accompanied by the number “25”, displayed on the pump screen. users are advised not to ignore this alarm and error message, which means that their pump has now stopped delivering insulin. if not, users could develop high blood sugar levels (hyperglycaemia).
  • Action
    Medtronic has contacted users who could potentially be affected and relevant health professionals to provide further information about this issue. Medtronic is advising users who experience this error to phone the Medtronic 24 hour Helpline (1800 777 808 - option 1). Users will be guided to troubleshoot to determine the cause of the error message and to perform a pump reset process which will reset the condition that caused the software anomaly. If the error cannot be corrected, the pump will be replaced. TGA will soon be publishing a web statement about this issue.

Device

MiniMed 640G Insulin Infusion Pump (with software version 2.6)
  • Modèle / numéro de série
    MiniMed 640G Insulin Infusion Pump (with software version 2.6)ARTG Number: 95763
  • 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