Published in the Journal of Diabetes Science and Technology

December 24, 2018

The article Reducing Glucose Meter Adverse Events by Using Reliability Growth With the FDA MAUDE Database is now online and here. 

Previous blog entries have mentioned the MAUDE database. The proposal is for manufacturers to use reliability growth to reduce glucose meter adverse events.

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Glucose Meter User Error – it’s not a rare event

December 6, 2018

Glucose meter evaluations, which are tightly controlled studies, are numerous and always show the same results – virtually all of the values are within the A and B zones of a glucose meter error grid. But a recent paper (1) shows that in the real world things are different.

In this paper, nurses and aides in a hospital, performed glucose meter tests and repeated the test when they felt that for some reason the result they obtained was suspect. Note that in a hospital with a patient right next to the nurse, a glucose value of less than 40 mg/dL with an asymptomatic patient would be suspect.

The good news is that in this hospital, retesting suspect results is part of the quality plan. Often the retested result was normal (e.g., 100 mg/dL or so higher than the first result). But of interest is the frequency of repeats, which was 0.8% (over 600,000 tests in the study). This leads to several comments…

The number of glucose meter tests performed each year is in the billions. The result from this hospital study implies that the number of incorrect results is in the millions.

User error is not rare!

Typical glucose meter evaluations, which never have this problem, are biased. Those evaluations are not representative of the real world.

There is more of a challenge for lay users performing self-testing (no nurse is present). Especially since asymptomatic hypoglycemia can occur.

References

  1. What Can We Learn From Point-of-Care Blood Glucose Values Deleted and Repeated by Nurses? Corl D, Yin T, Ulibarri M, Lien H, Tylee T, Chao J, and Wisse BE Journal of Diabetes Science and Technology 2018, Vol. 12(5) 985–991