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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Approximately 2% of infusion sets in the affected lots (lots starting with '8') may not allow the insulin pump to vent properly. venting is necessary to equalize the pressure in the reservoir compartment with the surrounding atmosphere. if the vent does not work properly this could result in too much or too little insulin being delivered.