The FDA spokesperson states in the document I cited above, "To evaluate pre-market submissions of blood glucose meters, FDA currently applies the principles outlined in our own guidance on glucose meters, and ISO 15197 Standard." I interpret this to mean that this ISO, as adopted by the FDA, does determine what the FDA deems acceptable.
Your reluctance to support further tightening this standard since "nobody would be able to manufacture the device" seems defeatist to me. We are surrounded by technical improvements in almost every facet of our lives. My 1994 car averaged 25 miles per gallon while my 2004 car averages 43 miles per gallon. Sometimes we need to provide incentives to the manufacturers to nudge them out of their comfortable niches.
The current standard for BG meters is old and outdated. A new, more accurate, and safer standard is needed to protect the safety of those that need insulin to live! If we make this a requirement, the manufacturers will adapt and learn how to produce a more accurate meter while still producing the profit they need to stay in business.
I got my G4 (my first CGM) 10 days ago. After the initial calibrations it was off 20% for the first 18 hours. Since, it's been within 10%, even with sensor change! Awesome device!
Useful Tip: Do not leave you G4 next to an eReader at night. It will cause it to lose signal for extended periods of time. I also hear the cordless phone bases will cause signal loss. My Nook was the culprit; every time it tried to download, my G4 would ??? for 3 hours.
As for Dexcom customer service; anyone find it nearly non-existent?
I have worn my first Dexcom Gen4 sensor for 8 days and I have had a few of the same problems your little guy did. The first 2 or 3 days my sensor took a while to become accurate. When I got my Dexcom 7+ I was told not to calibrate more then 3-4 times a day, so that is what I did with the Gen4 system.
After the first 3 days it is much more accurate than the 7, usually not more than 10 points difference between the receiver and my bg meter. I think the Gen4 is much better at detecting lows than the 7 also.
I am not computer savvy so I've not tried to download the Studio software, plus I've managed to misplace the device that plugs into the PC and the receiver....sigh
