Events

Recall of D-TRON INFUSION PUMP SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROCHE DIABETES CARE AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25908
  • Event Risk Class
    II
  • Event Initiated Date
    2002-09-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Manufacturer has received several worldwide reports of unintended programming or delivery of a small insulin bolus. the reports relate to a caved-in snap dome button of the up key on the pump keypad.

Device

D-TRON INFUSION PUMP SYSTEM
  • Model / Serial
    Model Catalog: (Lot serial: )
  • Product Description
    D-tron Pump
  • Manufacturer
    ROCHE DIABETES CARE AG

Manufacturer

ROCHE DIABETES CARE AG
  • Manufacturer Address
    BURGDORF
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    HC