Since the INRatio and a later model, the INRatio2, were cleared for use in 2002, the F.D.A. has received more than 9,000 reports of malfunctions with the products, and more than 1,400 reports of injuries, according to an analysis in December by the Public Citizen Health Research Group, a consumer organization. Reports of injuries associated with the INRatio devices are far higher than similar products on the market, a review of F.D.A. records shows.
The device’s problems also led last fall to a new analysis of a large drug trial that relied on the INRatio to monitor patients.
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