Events

Alerte De Sécurité sur QUICK-SET PLUS Infusion Set

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Medtronic Diabetes.

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
  • ID de l'événement
    774
  • Date
    2004-06-14
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    For the Brazilian users of insulin pump and its disposables, this communication is purely informative since the product involved in this process, Quick-set Plus is not commercialized in Brazil, nor compatible with MMT-506 pumps, MMT-507 and MMT-508 used in the country.
  • Cause
    Interruption of insulin flow in patients using this infusion set. this problem resulted in relevant complications, including hospitalizations.
  • Action
    Medtronic Comercial Ltda. communicates to its clients and healthcare professionals that it is conducting a recall process for the Quick-setÒ Plus infusion set in the United States because of problems that may interrupt the flow of insulin in patients using this infusion set. This problem has resulted in relevant complications, including hospitalizations. Medtronic is asking patients outside of Brazil to contact their customer service center by phone (800) MINIMED (1-800-646-4633) - USA, to exchange any Quick-set Plus infusion set not used by other infusion set models currently marketed by Medtronic. In the event that continued use of the Quick-set Plus infusion set is required while replacement infusion sets are in transit, Medtronic recommends that patients monitor their blood glucose frequently and are prepared to treat any elevated glucose levels that may occur through injections. Patients are also being instructed to contact their health care providers if there are excessive increases or decreases in glucose levels or any other question relevant to their treatment. Information on changing the Quick-set Plus infusion set is available at www.minimed.com/QSP. This recall applies to all Paradigm Quick-Set Plus infusion set models (models: MMT-359S6, MMT -359S9, MMT-359L6 and MMT-359L9). This action only affects Quick-set Plus infusion sets; no other equipment or infusion set manufactured by Medtronic are involved in this recall.

Device

QUICK-SET PLUS Infusion Set

Manufacturer

Medtronic Diabetes
  • Source
    ANVSANVISA