A diabetic woman using a medical device suffered a coma with her blood and brain in desperate need of sugar. However, the medical device instead kept pumping insulin into her body, starving her brain and making it unlikely that she would ever wake up. The woman was 17 weeks pregnant.
Although the device had a safety feature that stopped insulin flow in emergencies like the one the woman was experiencing, the feature was turned off when shipped to the woman. The instructional video devoted only 15 seconds to explain the feature and said nothing about why the feature should be used.
The woman suffered severe and permanent brain damage. The woman’s family sued the medical device manufacturer, alleging the medical device was unsafe . But when the device maker settled the lawsuit, the entire court file was improperly sealed. Moreover, the medical device maker failed to disclose this woman’s suffering and injury to the federal government, which could have used the report to spot problems with devices and to protect the public.
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