Seven Deaths, One Lesson: GRC Is a Lifeline, Not a Checkbox
Most people look at a headline about faulty medical devices and see a manufacturing error. What they miss is the underlying story about governance, risk, and compliance. The recent FDA alert tied to Abbott’s FreeStyle Libre 3 and Libre 3 Plus sensors is a reminder that GRC isn’t a back-office function. When it fails, the impact reaches real people in real time.
About 3 million sensors were found to be delivering falsely low glucose readings. According to the FDA, at least seven deaths and more than 700 serious injuries worldwide are linked to the issue. Roughly 60 injuries occurred in the US. Abbott identified the manufacturing cause, the FDA classified the problem as a high-risk issue, and both organizations urged patients to stop using affected sensors.
This is a public health crisis, but it is also a clear GRC lesson for every business, regardless of industry.
How GRC Shows Up in a Case Like This
Companies rarely think about GRC until something goes wrong. In reality, strong governance, disciplined risk management, and consistent compliance processes are exactly what keep situations like this from becoming catastrophic.
Here’s where GRC would have made the difference, based on established industry practice.
1. Governance sets the tone for accountability
A failure that affects millions of devices points back to governance. Not the board meetings or formal charters, but the real-world decisions that determine:
How quality controls are prioritized
How issues get escalated
How quickly risks trigger action
When governance is strong, manufacturing defects surface faster. Cross-functional teams know who owns the risk. There is a documented path that moves issues from engineering to leadership without delay.
Good governance doesn’t eliminate mistakes, but it ensures they can’t hide.
2. Risk management identifies the scenarios no one wants to think about
Continuous glucose monitors have a simple but high-stakes job. There are known risks: sensor drift, calibration issues, data transmission errors and adhesive failures. Mature risk programs map out these scenarios and stress-test them through:
Failure mode and effects analysis
Supplier and component risk assessments
Real-world environmental testing
Controls that detect abnormal patterns in production
None of this is theoretical. These are standard practices across medical device manufacturing. They don’t just reduce the chance of a defect, they narrow the window between defect emergence and defect detection.
In this case, inaccurate low readings created a predictable risk: patients may ingest unnecessary carbohydrates or skip insulin doses. That risk exists in every CGM product, which makes monitoring accuracy not just a product feature but a risk management obligation.
3. Compliance builds the operational muscle that catches issues early
Compliance in medical devices is not about checklists. It is about repeatable processes that create traceability from design to production to monitoring.
Systems required under FDA quality regulations, ISO standards and medical device reporting rules do the same thing at their core: they force consistency. Consistency is how you spot anomalies.
When a defect affects millions of sensors, the issue is rarely a single missed step. It is usually a weakness in how compliance processes catch and escalate deviations. Strong compliance won’t stop every issue, but it shortens the time between detection and response, which can save lives.
4. Incident response is part of GRC, not separate from it
Abbott and the FDA moved quickly to issue alerts, publish replacement information and outline patient actions. This is how incident governance should work. What many companies forget is that incident response is not just for cyber events. Product failures, data errors, vendor breaches, operational breakdowns, all fall under risk-based governance.
A mature GRC program includes:
Clear incident classification
Immediate cross-team coordination
External communication protocols
Regulatory reporting paths
This structured response matters when the stakes involve patient health.
Why Every Business Should Pay Attention
Your company may not manufacture medical devices, but the pattern is universal. When you strip away the headlines, this story is about a breakdown in the systems that are supposed to detect and contain risk.
GRC is the system.
It is the discipline that keeps teams honest, forces visibility into blind spots and ensures products, data and decisions stay reliable. When organizations invest in GRC, they are not investing in red tape. They are investing in the stability that protects customers, employees, partners and, in this case, lives.
This incident will fade from the news cycle, but the lesson should not. Strong GRC doesn’t make work slower, it makes outcomes safer. And as industries move toward AI, automation and connected products, the cost of getting GRC wrong only grows.
If this case proves anything, it is that no business can afford to treat GRC as optional. It is the quiet infrastructure that prevents the problems you never want to see on the front page.