Events

Alerte De Sécurité sur Freestyle Optium Neo Blood Glucose and Ketone Monitoring System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Abbott Diabetes Care.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-08-24
  • Date de publication de l'événement
    2015-08-24
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150824.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: freestyle optium neo blood glucose and ketone monitoring system it has come to our attention that medical device manufacturer, abbott diabetes care, has issued a field safety notice concerning a glucose and ketone monitoring system - freestyle optium neo blood glucose and ketone monitoring system. the manufacturer has become aware that a basal insulin titration feature of the affected product, which provides users with a long acting insulin dose suggestion, may in error recommend “0” units of insulin to be taken. this issue is encountered when the feature has been activated by healthcare professional (hcp), while the patient is in glycaemic control and their average fasting blood glucose level is within the target range that the hcp has set. the meter should suggest the basal dose that the patient took the prior day, but instead is incorrectly recommending “0” units. therefore, the manufacturer advises the users not to use this affected feature, if activated. according to the manufacturer, the issue would not pose a significant risk to user’s health or safety. the users may continue to test their blood glucose and/or ketones as this issue does not impact blood glucose and/or ketone results received from the meter. as a permanent solution, the manufacturer will update the firmware of the product. according to the local supplier, the affected product is distributed in hong kong; nonetheless, only those units with activated basal insulin titration feature would be involved. if you are in possession of the affected products and currently using the long acting suggestion, please contact your supplier and hcp for necessary actions. posted on 24 august 2015.

Device

Freestyle Optium Neo Blood Glucose and Ketone Monitoring System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Freestyle Optium Neo Blood Glucose and Ketone Monitoring System
  • Manufacturer
    Abbott Diabetes Care

Manufacturer

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
    DH