Abbott Glucose Monitors Linked to 7 Deaths and Hundreds of Injuries, NPR Investigation Reveals

A disturbing pattern of medical device failures has emerged as NPR's investigation revealed that Abbott's FreeStyle Libre glucose monitoring systems have been connected to at least seven deaths and hundreds of injuries. The findings raise serious concerns about the safety and reliability of these widely-used continuous glucose monitors (CGMs) that millions of Americans with diabetes depend on daily to manage their blood sugar levels.

The investigation, based on FDA adverse event reports and patient testimonies, highlights a critical gap in medical device oversight and patient safety protocols. Abbott's FreeStyle Libre, which captured approximately 28% of the global CGM market as of 2023, represents a significant portion of diabetes management technology relied upon by patients worldwide.

The Scope of the Problem

According to the NPR investigation, the FDA received over 60,000 adverse event reports related to Abbott's FreeStyle Libre devices between 2017 and 2023. Among these reports, the most serious cases involved device malfunctions that led to incorrect blood glucose readings, resulting in improper insulin dosing and severe medical complications.

The reported deaths were primarily attributed to severe hypoglycemia or diabetic ketoacidosis that occurred when patients relied on inaccurate readings from their glucose monitors. These life-threatening conditions can develop rapidly when blood sugar levels are not properly monitored and managed.

Understanding Continuous Glucose Monitors

Continuous glucose monitors are small, wearable devices that track blood sugar levels throughout the day and night. The FreeStyle Libre system, approved by the FDA in 2017, uses a sensor inserted under the skin to measure glucose in tissue fluid. Users scan the sensor with a reader or smartphone app to obtain current glucose levels and trends.

For the approximately 37 million Americans with diabetes, these devices represent a significant advancement over traditional finger-stick blood glucose testing. However, their reliability is crucial, as many patients use CGM readings to make critical decisions about insulin dosing, food intake, and physical activity.

Common Device Malfunctions

The investigation identified several recurring issues with Abbott's glucose monitors:

• Sensors providing falsely low or high glucose readings

• Complete sensor failures requiring premature replacement

• Adhesive problems causing sensors to fall off prematurely

• Software glitches in reader devices and mobile applications

Patient reports describe instances where devices showed normal readings while users were experiencing dangerous glucose levels. In some cases, patients reported that traditional fingerstick tests revealed significant discrepancies with their CGM readings, sometimes differing by over 100 mg/dL.

Abbott's Response and FDA Actions

Abbott Laboratories has acknowledged some device issues and has implemented software updates and improved user education programs. The company stated that the benefits of continuous glucose monitoring significantly outweigh the risks when devices are used as directed.

The FDA has not issued a recall but has worked with Abbott to address safety concerns through post-market surveillance and mandatory reporting of adverse events. The agency continues to monitor the situation and has requested additional safety data from the manufacturer.

Patient Safety Recommendations

Healthcare professionals and diabetes educators emphasize the importance of using CGM devices as part of a comprehensive diabetes management strategy. The American Diabetes Association recommends that patients continue to perform fingerstick blood glucose tests to confirm CGM readings, especially before making treatment decisions.

Key safety measures include:

• Regular calibration with traditional blood glucose meters

• Immediate medical attention for symptoms that don't match CGM readings

• Prompt reporting of device malfunctions to healthcare providers and the FDA

• Maintaining backup glucose testing supplies at all times

Looking Forward: Industry and Regulatory Implications

The NPR investigation has prompted discussions about strengthening medical device oversight and improving post-market surveillance systems. Medical device experts argue that current approval processes may not adequately assess long-term safety risks for complex devices like CGMs.

The diabetes technology market, valued at over $15 billion globally, continues to expand rapidly. As newer technologies emerge, ensuring robust safety standards and transparent reporting mechanisms becomes increasingly critical for protecting patient health and maintaining public trust in medical devices.

While continuous glucose monitors have revolutionized diabetes management for millions of patients, the reported safety issues underscore the need for continued vigilance, improved device reliability, and comprehensive patient education. As investigations continue, the medical community emphasizes that patients should remain engaged with their healthcare providers and never rely solely on any single monitoring device for critical health decisions.