Events

Safety Alert for insulin pumps MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-722, MMT-554, and MMT-754

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medtronic.

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
  • Date
    2014-03-19
  • Event Date Posted
    2014-03-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140319a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: medtronic insulin pumps medical device manufacturer, medtronic, has issued a field safety notice concerning medtronic insulin pumps. the affected model numbers are mmt-511, mmt-512, mmt-712, mmt-712e, mmt-515, mmt-715, mmt-522, mmt-722, mmt-554, and mmt-754. the manufacturer has received a small number of reports regarding users who have accidentally programmed the pump to deliver the maximum bolus amount, including one incident that resulted in severe hypoglycaemia. according to the manufacturer, when using the express bolus button to deliver a bolus, the down arrow will scroll to 0.0 units and stop. however, all insulin delivery programmed through the main menu will allow the down arrow button to scroll from 0.0 units to the programmed maximum insulin dose. the manufacturer advises users that because accidental button pressing errors may occur, it is important that patients always confirm the insulin dose flashing on the display is correct before pressing act to start delivery. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 19 march 2014.

Device

insulin pumps MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-722, MMT-554, a...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Teleflex Medical CAPIO Sutures
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH