I’ve been looking at the FDA adverse event database – MAUDE. For the first 7 months of 2018, there are over 500,000 adverse events, across all medical devices. There are just over 10,000 adverse events for glucose meters. Other diagnostic tests appear as well but it’s not surprising that glucose meters dominate, since billions of glucose meter tests are performed each year. Note that one person testing themselves three times daily yields over 1,000 tests per year and there are millions of people like this.
About 10% of the reported glucose meter adverse events are designated as injury with the rest designated as malfunction.
Published glucose meter evaluations and the MAUDE database are like parallel universes. Published glucose meter evaluations are controlled studies usually conducted by healthcare professionals where results that could be called adverse events occur rarely if at all. On the other hand, the MAUDE database contains only adverse events which are unverified and often unverifiable, and is usually conducted by lay people with a range of proficiencies.
Another huge difference is that glucose meter evaluations are a tiny sample of the population of glucose meter results. On the other hand, the MAUDE database is the population glucose meter results (although there are missing values because not all adverse events are reported).
Glucose meter evaluations appear often in the literature. There’s very little discussion about the MAUDE database.