FDA Warns Dexcom Over Glucose Monitor Problems

Law360, New York (June 2, 2010, 1:41 PM EDT) -- Medical device maker Dexcom Inc. failed to file reports that its blood glucose monitors had sensor malfunctions that could cause serious injury or death, the U.S. Food and Drug Administration contends.

Sensors broke off from Dexcom's Seven Plus series of blood monitors and remained embedded in the skin of dozens of patients, the FDA said in a warning letter to Dexcom publicized Tuesday.

The company was required to report the malfunctions to the FDA, but did not, the FDA said.

Under the Medical Device Reporting regulation...
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