Insulin infusion pump 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.

Risk of delay to treatment.There is an increased risk that the vibration alarm will not work, as a result of a changed component.  This fault will only be detected at pump start up, when it will display an ‘E-7’ error message and give an audible signal, but will fail to start.Roche will replace pumps that display this ‘E-7’ error message, but does not intend to replace all potentially affected pumps.