Reducing Glucose Meter Adverse Events by Using Reliability Growth With the FDA MAUDE Database

Area of Science:

• Medical Device Performance
• Biomedical Engineering
• Health Informatics

Background:

• Glucose meter evaluations assess device accuracy against established standards.
• Most glucose meters perform within acceptable accuracy zones (A and B) on error grids.
• The FDA Manufacturer and User Facility Device Experience (MAUDE) database is an underutilized resource for device performance insights.

Purpose of the Study:

• To highlight the potential of the MAUDE database for understanding glucose meter malfunctions.
• To introduce reliability growth management as a strategy for reducing device failures.
• To explore the application of reliability growth management to improve glucose meter safety and performance.

Main Methods:

• Analysis of glucose meter performance data from common evaluations.
• Review of adverse event reports submitted to the FDA MAUDE database.
• Presentation of a reliability growth management example and its potential application.

Main Results:

• Common evaluations show most glucose meters meet performance guidelines.
• The MAUDE database recorded 10,837 adverse events for glucose meters in early 2018.
• Reliability growth management is a proven method for decreasing failure rates.

Conclusions:

• The MAUDE database offers valuable, underutilized data on glucose meter real-world performance and failures.
• Reliability growth management presents a viable strategy for proactively reducing glucose meter malfunctions.
• Integrating MAUDE data with reliability growth principles can enhance glucose meter safety and reliability.