Events

Safety Alert for QUICK-SET PLUS Infusion Set

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medtronic Diabetes.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    774
  • Date
    2004-06-14
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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