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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A small number of animas 2020 insulin infusion pumps are potentially affected by a misalignment of a component on the printed circuit board assembly. this component misalignment results in the insulin pump potentially measuring force conditions incorrectly resulting in false warnings and/or alarms. should the patient complete a load sequence or prime the insulin infusion pump and does not disconnect from the infusion set from the body the insulin infusion pump may dispense all of the insulin in the cartridge into the patient. there is no safety risk as long as the patient follows the instructions for use and always disconnects the infusion set prior to priming the pump changing the cartridge and rewinding the motor.