It's Only FAERS

Some of you may be familiar with the difficulties I’ve been having with my very expensive, cutting-edge Class III medical device. In a nutshell, I discovered the first month that the cutting-edge tech, which was supposed to act as an intuitive pancreas, did not work for me. I called the manufacturer and they had no solution for me. I asked to talk to someone who knew more about how the algorithm worked, an engineer, but of course, there was no one like that available. All they had was the customer service reps who knew less than I did. I had to turn that part of it off.


Then, a few months ago, the “insulin flow blocked” alarm started going off, about every other day, mostly in the middle of the night. You can’t turn it off. Sometimes it seemed fixed, but went off the next hour. And the next. Each time, when the insulin wasn’t properly delivered, my blood sugar drifted up and then had to be treated once the machine was working again, which was arbitrary at best.

This went on for two months, gradually draining my sleep until I was just this side of zombie. I called the manufacturer this time, too. By then, the company was offering “specialists” in their new tech, but as someone who has worn an insulin pump for 18 years, I had already tried everything on the representative’s troubleshooting list. The only option was to give me an infusion set (where the insulin goes into the body) that would leave the metal needle in my body, instead of the usual small flexible plastic. Both my doctor and I were a hard no on that one. At this time, she did not offer to replace the pump.

Finally, on January 27, the pump rejected a new battery. This prompted a 2:30 a.m. call to the manufacturer. I told them – I didn’t ask – that they were sending me a new pump. Thankfully, after taking a quick look at the notes in their files, this rep complied immediately.

After that long, I was frustrated and a little angry that over the course of a year, the tech that was supposed to make my life easier had made it that much harder. I had spoken with the manufacturer three times in less than a year, but I wanted to lodge my complaints with someone who didn’t have a stake in how well the tech performed. But, as far as I knew, the closest I could get was the Better Business Bureau, which seemed a stretch. The manufacturer wasn’t doing bad business. They were inadequately addressing technology that could make people very sick.

Recourse for a Faulty Device

As luck would have it, a week after my 2:30 a.m. call, I attended a conference where one of the speakers was from the FDA. He told me that the FDA tracks these sorts of incidents through their FDA's Adverse Event Reporting System (FAERS). It makes sense – they have to know whether the devices they approve are doing what the company says they should, and whether the manufacturers are properly reporting when they don’t. FAERS also tracks cases where medication causes issues.

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I know I’m not the only one who has had incidents with medical tech. I am lucky that I can control mine. (I can remove the battery and go to injections every 2.5 hours, and I did on several occasions, but it doesn’t solve the tech problem.) It’s not like an artificial knee that doesn’t function properly or, even more dangerous, a pacemaker on the fritz.

I suspect that I am not the only one who didn’t know about FAERS. But now I do know, and I have used it to report my issues with a device my life depends on. As users of medical tech (and medication), we have a responsibility to report when it doesn’t work. Beyond the cathartic benefit of venting to people who can do something about it, we owe it to ourselves and future users to hold manufacturers accountable and pass on information the manufacturers can use to improve the next generation of devices (and medication).

It’s only FAERS.