DexCom receives Warning Letter from FDA

Just FYI…

This has to do with sensor wire fractures retained underneath one’s skin after sensor removal. Apparently, this problem has led to complications (including surgery requiring general anesthesia in small children) for several patients and DexCom has not been reporting this problem completely. There is also mention of off-label use in children and adolescents and off-label use in areas other than the abdomen.

If you are interested, you can read the warning letter FDA’s web site at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm213414.htm

DexCom is having a conference call at 4:15 pm EST to discuss. Information about the conference call follows: "To listen to the
conference call, please dial (800) 447-0521 (US/Canada) or (847)
413-3238 (International) and use the confirmation number
“27189814”
approximately five minutes prior to the start time. The conference
call
will be concurrently webcast. The link to the webcast will be
available
on the DexCom, Inc. website at www.dexcom.com
under the investor webcast section and will be archived for future

reference."

Thanks for sharing this. I have had bent wires when removing the sensor, but have not retained a wire that I am aware of. YIKES!

Thank you for posting this. I will try to call & listen to the conference call. Prior to getting the Dexcom, I had a Navigator and was a part of their big backorder problem. That started in Jan & is still going on & Abbott still is not talking about what is happening. It is nice to Dexcom get out their & address this right away.

Thanks for sharing this information. For those of you who did not hear the original webcast you can find the recording of DexCom’s comments at

http://investor.shareholder.com/dexcom/eventdetail.cfm?eventid=82300

AaronM

Interesting to listen to the call, in large part for me for the Gen 4 comments. Clinical trials of the Gen 4 sensor are being done this summer, and supposedly that sensor has greater accuracy and sensitivity to hypoglycemia. Also, the sensor wire will be 8x stronger than the existing wire. They also discussed the placement of the sensor in the abdomen versus other parts of the body. They said there was no relation between length of sensor use and wire failure (ie if you use a sensor longer than 7 days you are not more likely to have the wire fail). Failure rates were quoted as 3 out of 10,000. They also said if a wire fails, nothing needs to be done…the body will eventually expel it.