Dexcom, Inc. = February 8, 2010
Issue Date
Feb 08, 2010
Region
Pacific
Category
Device
$117.00
Address 1
6340 Sequence Dr.
City
San Diego
State
CA
Zip/Postal Code
92121
Country
US
Inspection Range
Jan 11, 2010 - Feb 08, 2010
Pages
5
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Trudy R. Papson