Manufacturers classify events differently

October 20, 2019

In continuing to analyze the adverse event database – this time for continuous glucose monitors (CGM), I noticed something very strange. There are two major manufacturers each with their latest product. This is the result. To recall, events are classified as either M=malfunction, IN=injury, or D=death.

Manufacturer Percent events classified as injury
A 94%
B 0.2%

But the text for these events is similar. How can this be?

Analyzing the adverse event database

October 7, 2019

Looking at glucose meter adverse events from the FDA database, an SQL query showed that 73% of the time, a form of the verb allege was used by manufacturers to describe the event, as in “the user alleged that …” This is I guess one way of acknowledging that these events are unverified.