Events

Rappel de Medtronic MiniMed Insulin Reservoirs

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-2013-RN-00690-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-07-05
  • 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-2013-RN-00690-1
  • 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
    There is the potential that reservoirs from the affected batches may have an increased risk of leaking. a leak in the reservoir may result in delivery of less insulin than needed. in addition, if the user has a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not alarm to notify them.
  • Action
    Medtronic Diabetes is requesting customers to not use reservoirs from the affected batch. If no alternative product is available, customers are requested to switch to their back-up insulin injection plan. Replacement of affected batches can be arranged by contacting the Medtronic 24 Hour Help Line. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-minimed-130716.htm .

Device

Medtronic MiniMed Insulin Reservoirs
  • Modèle / numéro de série
    Medtronic MiniMed Insulin ReservoirsModel Numbers: MMT-326A and MMT-332ABatch Numbers: H8442973, H8463297, H8467888, H8469703, H8473271, H8478398, H8492449, H8494645, H8496561, H8510440, H8512826, H8517079, H8539013 and H8627745ARTG Number: 169959
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • 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