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Friday, January 13, 2017

FDA MAUDE, Patient Outcomes and "8."

The FDA's MAUDE database contains reports on malfunction of medical devices. You can run more comprehensive searches here.

There's a lot of information buried in the MAUDE database, including the outcomes of patients who were on the receiving end of a malfunctioning device.

Specifically, the MAUDE database uses a 1-letter code to list the following possible outcomes:
  • Congenital Anomaly (C)
  • Death (D)
  • Disability (S)
  • Hospitalization (H)
  • Life Threatening (L)
  • Other (O)
  • Required Intervention (R)
  • plus a few others that are not particularly interesting.
Lately, the FDA has stopped listing patient outcomes and have replaced them with the following cryptic message: 8.  That's right, the digit 8 and a period. I have no idea what that means, but there has been no patient outcome information (other than "8.") in the MAUDE database for ALL of 2016.

Let's take a look (blue line below) at the rise of "8." If we go back to 2012 and 2013, we can see that only 1 - 5% of MAUDE reports had an outcome of "8."

Things start to change in the spring of 2015, when "8." begins an exponential march upward.

By October 2015, 100% of the MAUDE reports show an outcome of "8." and it hasn't relinquished its stranglehold since.

I have no idea what "8." means. 

  • Is it a database error? 
  • Does it mean that the FDA has stopped releasing this information?
  • Something else entirely?

If anyone knows what "8." means, please let me know!!!

Here's some additional weirdness.

The graph shown above only goes back to late 2012.
You can go all the way back to 1991 and plot MAUDE outcome data.
What you see are periodic spikes of "8." (see blue line in chart below).

Again, I have no idea why "8." would take up 30+% of the patient outcomes in September of 2004, but it's there.