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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Customers using the accu-chek spirit combo systems were experiencing an increase of mechanical/rewind errors with their insulin pumps showing e6 and e10 errors caused by damage of the telescope gear of the cartridge compartement due to insulin residuals as a result of handling errors.