Check Your Continuous Glucose Monitor—Abbott Warns of Potential Incorrect Readings For 3 Million Products

# Check Your FreeStyle Libre: Abbott Issues Urgent Warning Over Inaccurate Glucose Readings

For millions of people managing diabetes, a Continuous Glucose Monitor (CGM) is more than a device—it’s a lifeline. It provides a constant stream of data, helping to prevent dangerous high and low blood sugar events. That’s why a recent safety notification from Abbott, the manufacturer of the popular FreeStyle Libre family of CGMs, is causing concern. If you use one of their devices, it’s time to pay close attention and **check your continuous glucose monitor—Abbott warns of potential incorrect readings for 3 million products** currently in use in the United States.

This isn’t just a minor glitch; it’s a significant alert that could impact your health and diabetes management. This article will break down exactly what the warning means, which products are affected, and the crucial steps you need to take to ensure your safety.

## What is the Abbott CGM Warning About?

In late 2022 and early 2023, Abbott initiated a “Medical Device Correction” for several of its FreeStyle Libre CGM systems. It’s important to understand that this is not a full product recall where you need to send your device back. Instead, it’s an urgent safety notification designed to make users aware of a potential problem and provide guidance on how to manage it.

The core issue is that a limited number of sensors from specific lots could provide falsely low glucose readings. This poses a significant health risk.

### The Specific Problem: False Low Glucose Readings

The primary concern highlighted by Abbott is the potential for the CGM sensor to report blood glucose levels that are much lower than they actually are. This can lead to two dangerous scenarios:

1. **Unnecessary Treatment:** A user sees a low reading on their CGM and, believing they are experiencing hypoglycemia, consumes sugar, glucose tabs, or a sugary drink to raise their blood sugar. If the reading was false, this action could needlessly push their actual blood sugar into a high range (hyperglycemia).
2. **Missed Hyperglycemia:** A user’s blood sugar might actually be in a high or even dangerous range, but the faulty sensor reports a normal or low number. This could cause them to miss a necessary dose of insulin or other corrective action, allowing hyperglycemia to persist, which can have serious short-term and long-term health consequences.

Abbott has stated that this issue may occur when a user restarts the sensor for a new session after the initial wear period has ended. The company has always maintained that the sensors are designed for a single, continuous wear period (typically 14 days).

### How Many Products Are Affected?

The warning applies to a large number of devices—potentially impacting up to 3 million products distributed in the U.S. market. However, it’s crucial to note that this does not mean all 3 million sensors are faulty. The issue is limited to specific manufacturing lots. The broad scope of the warning is a precautionary measure to ensure all potentially affected users are informed.

## Which FreeStyle Libre Products Are Included in the Warning?

The safety notification specifically covers the following widely used systems in the United States:

* **FreeStyle Libre**
* **FreeStyle Libre 14 day**
* **FreeStyle Libre 2**

It is important for users of these specific systems to be particularly vigilant. While the newer FreeStyle Libre 3 system is not explicitly named in this particular correction, all CGM users should practice the safety steps outlined below as a matter of good diabetes management.

## Your Action Plan: What Should You Do Right Now?

Hearing about a potential issue with a critical medical device can be stressful, but there is a clear and simple action plan you can follow to stay safe.

### Step 1: Don’t Panic, But Be Proactive

The first step is to understand that this is a *potential* issue. Your sensor may be working perfectly. The goal of this warning is to empower you with knowledge so you can identify a problem if it occurs. Continue using your CGM as prescribed, but with a heightened sense of awareness.

### Step 2: Know the Symptoms of High and Low Blood Sugar

Your body often provides the best clues. If your CGM reading doesn’t match how you feel, it’s a major red flag. Re-familiarize yourself with the common symptoms:

* **Symptoms of Hypoglycemia (Low Blood Sugar):** Shakiness, sweating, dizziness, confusion, rapid heartbeat, irritability, headache, weakness.
* **Symptoms of Hyperglycemia (High Blood Sugar):** Increased thirst, frequent urination, fatigue, blurred vision, headache, dry mouth.

### Step 3: Always “Trust Your Gut” and Verify with a Fingerstick

This is the most critical piece of advice. The golden rule of CGM use has always been: **if your reading doesn’t match your symptoms, do a fingerstick test.**

A traditional blood glucose meter (BGM) provides a direct measurement of the glucose in your blood at that exact moment. It should be your source of truth for making treatment decisions, such as taking insulin or consuming sugar, especially if you have any doubts about your CGM reading. Do not make a treatment decision based on a CGM number that feels wrong.

### Step 4: Check Your Sensor’s Lot Number

Abbott has created a dedicated website to help users determine if their sensor is from an affected lot.

* **Find the Lot Number:** The lot number is a unique identifier printed on the box your sensor came in and on the individual sensor packaging.
* **Visit the Website:** Go to **www.FreeStyleConfirm.com**.
* **Enter Your Lot Number:** Type the lot number into the checker tool on the site. It will immediately tell you if your sensor is part of the affected group.

If your sensor is on the list, it doesn’t automatically mean it will fail, but you should be extra cautious and follow the verification steps closely.

### Step 5: Contact Abbott Customer Service if Needed

If you have experienced a problem with false low readings, confirmed that your sensor is from an affected lot, or have any other questions, you should contact Abbott’s customer service directly. They can provide guidance and arrange for a replacement sensor if necessary.

## Why Accurate CGM Readings Are So Important

This warning underscores just how vital accurate and reliable technology is for diabetes management. CGMs have revolutionized care by providing a dynamic view of glucose trends, helping users and their healthcare providers make informed decisions about insulin, diet, and exercise. An accurate CGM helps:

* **Prevent Severe Hypoglycemia:** By alerting users to falling glucose levels before they become dangerous.
* **Improve Time in Range (TIR):** By helping users keep their blood sugar within a target range for more of the day.
* **Reduce A1c Levels:** By providing the data needed for better overall glucose control.

When that trust is compromised by potential inaccuracies, the entire system of management is at risk. That’s why Abbott’s proactive warning, and your proactive response, are so essential. As a user, staying informed and prepared is your best defense.