Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Medtronic.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 025 01 19 000
  • Date de mise en oeuvre de l'événement
    2019-01-10
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13734
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    The purpose of this letter is to advise you that your pump has an error that impacts the arabic language translation. if you do not use the arabic language setting on your pump, you may disregard this message. this translation error does not impact the functionality of the device. devices do not need to be returned. additionally, we are not aware of this error occurring on any other medtronic insulin pump models. this translation error occurs in the “predictive alerts” setting screen, which allows you to program alerts that will sound if you are predicted to reach your pre-set low or high sensor glucose values. for your reference, below is a step-by-step guide on where you will find the arabic language translation error: 1. “main” > “sensor” > “edit settings” 2. select “predictive alerts”, then press “act”. the “predictive alerts high/low” screen may show that the alerts are turned off. 3. select “on”, then press “act”. the “set time sensitivity high/low” screen will appear. kindly check the photo in the attached fsn the “ منخفض / مرتفع “ header is incorrectly labelled in the arabic language setting and should instead read “مرتفع / منخفض ”. the value to program the low predictive alert setting is on the left, and the value to program the high predictive alert setting is on the right.

Device

MiniMed™ Paradigm™ Veo™ Insulin Pump
  • Modèle / numéro de série
    MiniMed™ Paradigm™ Veo™ Insulin Pump
  • Description du dispositif
    Insulin Pump
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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.
  • Représentant du fabricant
    Medtronic Saudi Arabia
  • Source
    SFDA