U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Insulin Infusion Pumps - Product Code LZG
원인
Exposure to magnetic resonance imaging (mri) has resulted in damage to the component that monitors and controls movement of the motor in the minimed paradigm insulin infusion pump. although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemi.
조치
Firm mailed Medical Device Safety letters on April 24, 2007, to healthcare professionals, existing pump users and MRI facilities reiterating the existing warning in the pump User Guide to avoid exposing the pump to MRI (or similar high strength electromagnetic fields) and strengthening previous warning by specifically mentioning the potential for over-delivery and severe hypoglycemia. Firm is also including an insert with this information with any Paradigm infusion pumps shipped to new customers.