Reporting a Device Injury as a Patient

As someone who likes to experiment with my diet, I’ve always been curious about real-time glucose monitoring. I wanted to see how different foods—especially things like fruit, bread, or heavy meals—impacted my blood sugar. So when I had a chance to try out a continuous glucose monitor (CGM), I was eager. It’s not something I needed, just a personal experiment with my body.

Unfortunately the Abbott Lingo biosensor I used only works on iOS (my wife purchased a gift, not realizing this). So, I had to use my wife’s iPhone to pair the sensor and occasionally check-in with the data. Once up and running, it sampled every five minutes.

What did I learn? Not much. Aside from being consistently in the 85–95 mg/dL range, I noticed occasional midnight spikes while I was asleep—possibly from getting up to use the bathroom or maybe something more metabolic. It was interesting, but nothing earth-shattering.

Unfortunately, things took a turn.

Data Curiosity to ER Visit

Just five days after applying the sensor, the app notified me that the biosensor had expired prematurely. I removed it as instructed. Within a day, I noticed increasing redness and swelling in my upper right arm where the sensor had been applied. I went to UNC Urgent Care, where I was prescribed a short course of Bactrim and a marker outline of swelling. My discomfort and pain didn’t resolve, and by day three, I ended up in the ER. The diagnosis? Cellulitis and an abscess requiring incision and drainage, followed by more antibiotics.

This wasn’t a minor rash or irritation. It required real medical intervention, including a surgical procedure and prescriptions. I used the device exactly as instructed: I cleaned the area thoroughly with the alcohol wipe provided and used the application device properly. I also exercised and showered while wearing the device—both of which the manufacturer permits.

Reporting the Adverse Event: Manufacturer vs. FDA

As I recovered, I decided to do something I imagine few patients consider: I reported the incident to both the manufacturer and the FDA. Why? I wanted to understand the process. Medical device safety often seems behind closed doors and removed from the patient experience. This was a chance to see how the system handles a real event—especially when it’s voluntary.

Here’s what I learned.

Abbott’s Response

I contacted Abbott (Lingo Customer Support) and received a fairly minimal intake request. Here’s a screenshot of their questions:

The questions were mostly logistical: how many days I had worn the sensor, the serial number, shipping address, and a few symptom-related questions. It was bare bones and didn’t feel thorough. More importantly, it didn’t give me a sense that this information would be acted upon or trigger any formal investigation. To be fair, I don’t know what manufacturer reporting looks like (though you can glean some details from MAUDE records, like this one).

FDA MedWatch Submission

Compare that to the FDA’s MedWatch Form 3500B, which I submitted voluntarily as a consumer. It’s more detailed, structured, and collects clinical information. It includes dates, diagnoses, test results (like the ultrasound) around the severity of the issue, and relevant questions for existing medical conditions, known allergies, current medications:

This information is destined for FDA’s MAUDE (Manufacturer and User Facility Device Experience) database, which is searchable and public. As of this writing, my report hasn’t been published yet. I’m curious to see whether the manufacturer files a corresponding report, whether the FDA cross-references or merges them, and what happens—if anything—on the regulatory or compliance side.

Why It Matters

Let’s be balanced here: this was a minor harm and known risk with CGM devices. But as a patient—not a researcher, not a clinician—undertaking this was important to a well-functioning safety surveillance system. There’s a huge difference in how thoroughly the FDA vs. a manufacturer collects data. The burden of reporting, especially in a system where most people would never think to file a MedWatch report, falls on the patient.

In an age where data—especially PHI—is highly valued, it’s worth asking how many adverse events go unreported. What is the risk of infection for a CGM? Especially in a larger consumer population.

I have no idea what, if any, impact such reports have on Abbott’s design and manufacturing processes. Presumably events like these are considered by their quality systems team. But as someone who works on early-stage medtech, I now have first-hand experience with how safety reporting works—or doesn’t—for patients.

I plan to post an update once my report appears in the MAUDE database. Until then, I’m left wondering:

How do we track patient safety in an age where the line between medical devices and consumer wearables is increasingly blurred?