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.
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Roche has received customer complaints related to defective capacitor where date and time setting were lost and power interruption typically upon battery change if the user does not set date and time correctly after restart of an affected pump as stated in the manual the pump may deliver medication based on a time shifted basal profile.