Abbott Recalls Defective Blood Glucose Monitors
Abbott Diabetes Care has issued a recall for all FreeStyle Flash Blood Glucose Monitoring Systems and FreeStyle Blood Glucose Monitoring Systems following reports of incorrect readings which have led to serious injury and death.
About the Abbot Diabetes Care Recall
According to Medscape, Abbot is advising consumers to stop using the FreeStyle Flash Blood Glucose Monitoring Systems and FreeStyle Blood Glucose Monitoring Systems as testing has shown that Freestyle strips can result in erroneously low blood glucose readings.
In addition to the two FreeStyle monitors, Abbot has also stated that consumers using the Omnipod Insulin Management System should stop using the built in monitor until Abbott can replace the defective test strips.
The current recall is an extension of a November recall in which 20 specific lots of FreeStyle and FreeStyle Lite blood glucose test strips were deemed defective – the U.S. Food and Drug Administration (FDA) labeled the incident a Class 1 recall meaning there is a reasonable probability that use of the recalled strips and monitors will lead to serious injury or death.
Serious Injury and Death Reported to the FDA
The FDA has received multiple reports of serious injury and death attributed to the defective blood glucose monitors and test strips.
According to one report, a patient developed hyperglycemia and then diabetic ketoacidosis after receiving repeated erroneous blood glucose readings while using the Omnipod Insulin Manager. She died as a result.
Another consumer reported that her husband received various readings ranging from 58 to 132 within a 5 minute period. while a third noted readings which varied by more than 100 points, leading her to believe that her daughter's blood sugar was at a safe level.