Events

Safety Alert for Paradigm Quick Set Infusion Catheter Medtronic - Registration No. 10339190272, Model MMT-396; MMT-397, MMT-399 - Infusion Catheter Paradigm Silhouette Medtronic - Record no. 10339190273, Model MMT-377, MMT-378 - Paradigm Medication Reservoir - Registration No. 10339190270, Model MMT-326A, MMT-332A

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

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
    1279
  • Date
    2013-06-12
  • 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
    The batches of the Paradigm Medication Reservoir product reported on this alert were marketed from October 2012 to May 2013. Any questions, please contact Medtronic at 08007739200. #### UPDATE: The field action was finalized by the company on 11/18/2013.
  • Reason
    Medtronic is developing two concurrent field actions related to medtronic's paradigm infusion system, one for safety and another for recall. a) the first relates to a safety problem that may occur if insulin or other fluids come into contact with the medtronic paradigm infusion set connector. exposure from the inside of the infusion set connector to the insulin may occur if the insulin is spilled on top of the insulin reservoir when the reservoir is removed from the blue transfer shield after filling the reservoir from an insulin bottle. if this occurs, insulin may temporarily block the openings in the connector that allow the pump to function properly. if the openings are blocked, this can probably result in the delivery of more or less insulin, which can lead to hypoglycemia or hyperglycemia, which in extreme cases can lead to loss of consciousness or death. b) the second field action refers to the collection of some batches of reservoirs, model mmt-326a and mmt-332, used with the paradigm insulin infusion pumps, due to the risk of leakage. a leak in the reservoir may result in the delivery of less insulin than is programmed, and if there is an occlusion in the infusion set, the pump may not report through the alarm.
  • Action
    A) the company advises that, in order to prevent insulin from blocking the connector openings, the user should: 1. After filling the reservoir, ensure that the insulin bottle is kept upright when removing the insulin shield reservoir. blue transfer. This prevents insulin from inadvertently leading to the top of the reservoir, which could transfer the insulin into the infusion set connector. Hold the insulin bottle upright when removing the reservoir. 2. If any liquid (such as insulin, isopropyl alcohol, or water) reaches the top of the reservoir or the inside of the infusion set connector, start again with a new reservoir and infusion set. B) As for the reservoir, it is important that the user verify that the batch numbers of all MMT-326A and MMT-332A reservoirs in their possession are listed in the letter attached to this alert. You can also check the batch number of your reservoirs at the following site http://www.medtronic-diabetes.info to confirm whether your reservoirs are included or not in this action. If all reservoirs held by the user are involved in the recall, the company recommends that the use be immediately stopped and the user to use syringe or pen for the administration of insulin, as prescribed by their physician until that receives new reservoirs. The company directs that any reservoir that has not been used and included in this recall should be discarded, but that the bar code label of the container box or the individual containers of the containers should be maintained since these will be required to submit an order of reservoir replacement. Reservoirs whose batches are not listed in this alert can be used. The company informs that it will replace all the reservoirs of the affected lots at no cost. For more information, please refer to the letters attached to this alert, as well as the company's website: http://www.medtronic-diabetes.info.

Device

Paradigm Quick Set Infusion Catheter Medtronic - Registration No. 10339190272, Model MMT-396; MMT...

Manufacturer

Medtronic Comercial Ltda
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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.
  • Source
    ANVSANVISA