6 results

• Medical Device Manufacturers Often Fail To Submit Timely Adverse Event Reports to FDA: Study

  March 19, 2025

  Martha Garcia

  The findings of a new study indicate that medical device manufacturers turn in a third of all adverse patient event reports later than legally required.

• Freestyle Libre Recall Issued For 4.2M Glucose Monitors After Reports of Fires, Extreme Heat

  April 7, 2023

  Russell Maas

  A Freestyle Libre glucose monitor recall was announced after the FDA received more than 200 reports of overheating, fires and at least one patient injury.

• Abbott FreeStyle Libre Glucose Monitor Warning Issued Over Battery Problems, Overheating Risks

  April 6, 2023

  Katherine McDaniel

  Abbott is warning customers that its FreeStyle Libre glucose monitoring systems may be prone to their lithium ion batteries overheating, leaking and sparking fires.

• GenStrip Blood Glucose Test Strips May Give False Results, FDA Warns

  April 30, 2014

  Russell Maas

  The FDA warns that Genstrips blood glucose test strips may give false results, leading to diabetes decisions that could endanger patients.

• OmniPod FreeStyle Glucose Recal Issued Due to Erroneous Results

  April 14, 2014

  Russell Maas

  Another Abbott blood glucose freestyle meter has been recalled due to erroneous test strip readings.

• Blood Glucose Meter Problems May Lead to New FDA Guidelines

  January 14, 2014

  Irvin Jackson

  The FDA is considering new guidelines on the accuracy and durability of blood glucose meters for testing diabetic blood sugar levels.