DexCom is warned over wire fractures, warning labels

06/1/2010 | San Diego Union-Tribune

The FDA warned DexCom, a maker of glucose-monitoring devices, regarding its failure to properly report fractures in its monitoring wires. The agency also advised the company to include more information in the warning labels for two of its products. DexCom CEO Terrence Gregg said he doesn't see the warnings as a major issue because the company will redesign the labels and had already reported the fracturing issue. An analyst said the FDA's letter was "a pretty mild warning letter, as warning letters go."

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