Events

Rappel de FreeStyle InsuLinx Blood Glucose Meter (An in vitro diagnostic medical device (IVD))

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

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-00321-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-04-12
  • 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-00321-1
  • 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
    Abbott have determined that at extremely high blood glucose levels (56.8 mmol/l and above), the device will display and store in memory an inaccurate low result that is 56.8 mmol/l below the genuine result. for example, for a blood glucose result of 59.1 mmol/l, the meter will display and store a result of 2.3 mmol/l (59.1 mmol/l - 56.8 mmol/l = 2.3 mmol/l). if this occurs there may be a delay in identification and treatment of high blood glucose levels, or incorrect treatment may be recommended by the insulin calculator, if this feature is enabled on the meter.
  • Action
    Abbot Diabetes Care has developed a software correction for the problem and is asking users with access to the internet to update the software of the device. For more details, http://www.tga.gov.au/safety/alerts-device-freestyle-insulinx-130417.htm .

Device

FreeStyle InsuLinx Blood Glucose Meter (An in vitro diagnostic medical device (IVD))

Manufacturer

Abbott Australasia Pty Ltd T/A Abbott Diabetes Care
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA