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Re: [IP] darn meter reliability problems Accuchek Advantage

<email @ redacted> wrote:

> I would call the company and explain your problem.  Perhaps they would send 
> you some Comfort Curve strips to try.

I'm going to put on my professional hat to respond to this (I work in the Division of Laboratory Systems, Public Health Practice Program Office of the Centers for Disease Control and Prevention.  The Standards Branch is responsible for establishing the standards of laboratory proficiency).  

By all means, work closely with the manufacturer.  Home glucose meters fall into the category of waived laboratory tests under the Clinical Laboratory Improvement Act of 1988 (CLIA 88).  In order for a device/test to qualify as waived it must meet two criteria: the device must be usable, and written instructions understood by someone with a seventh grade education, and the resulting tests must be within 5% of a standard test (i.e. non-waived laboratory test) 50% of the time.  *Unofficially* that works out to +/- 20% of the standard lab test.

If you get a result that you just feel is inaccurate, test again.  If it tests the same, then the first one was probably accurate within the 5% standard.  If not, then you can decide to test yet again, or choose which test to believe.  It's a good idea to take your meter with you when you have blood drawn for lab tests (such as fasting serum glucose), test at the same time blood is drawn, and compare your reading with the lab result.  Don't forget to compensate for blood/serum differences if necessary.

If you suspect your meter is consistently inaccurate, contact the manufacturer.  Their replacement policies are generally very liberal as they don't want any body of evidence being built that their meter is not meeting waived test criteria.

There is, BTW, a new meter (Prestige?) that is being advertised as being accurate within 3%, not 5%.  A claim like this *must* be based on data.  If no claim is made of greater accuracy, then it is the same as all the others.  The decision of which brand to use, then, is based on other factors (except, perhaps, for the new one).

Changing subjects, my pump arrived on Friday and I'm waiting for training like a kid waiting for Christmas.

Jim Handsfield
mailto:email @ redacted

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