Events

Rappel de FREESTYLE PRECISION NEO BLOOD GLUCOSE AND KETONE MONITORING SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION.

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
    40498
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-07-20
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Abbott diabetes care has become aware that the freestyle precision neo blood glucose and ketone monitoring systems may not function as intended. a meter firmware defect was identified affecting the basal titration (long-term insulin dose recommendation) feature for patients using long-acting basal insulin where the suggested insulin dose displays as 0u (units) instead of the basal insulin dose if no titration occurs after the target timeframe (set by the hcp) ends and the average fasting blood glucose level is within the target range set by the hcp. abbott diabetes care has determined that this issue does not pose a significant risk to users' health or safety.

Device

FREESTYLE PRECISION NEO BLOOD GLUCOSE AND KETONE MONITORING SYSTEM
  • Modèle / numéro de série
    Model Catalog: 71385-75 (Lot serial: METERS SHIPPED TO HCPs)
  • Description du dispositif
    FREESTYLE PRECISION NEO BLOOD GLUCOSE AND KETONE MONITORING SYSTEM
  • Manufacturer
    ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION

Manufacturer

ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION
  • Adresse du fabricant
    MISSISSAUGA
  • 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
    HC