Alert on Certain LifeScan Blood Glucose Meters (July 2005)

LifeScan, Inc, is notifying users of some of the company's blood glucose testing systems about possible problems that might cause misinterpretation of glucose test results. The affected meters are the OneTouch® Ultra®, the OneTouch® FastTake® and the InDuo® Systems.

These three meter systems were originally designed to allow patients to select one of two units of measure to display their test results. This allowed patients to see their test results in the units customarily used in their own country. Some other companies' meters also let the patient select the proper measurement units.

The feature on these LifeScan meters allows the patient to switch between mg/dL, the standard used in the U.S. and mmol/L, which is used in many other countries. When setting the meter's date and time, it's possible for patient to accidentally switch over to the other measurement units without realizing it, and then, just looking at just the numbers, misinterpret the results and incorrectly assume that the blood glucose level is too high or too low. Over the past year or so, FDA has received several dozen reports of these kinds of errors.

In addition, the measurement units can also be accidentally switched if the meter is dropped while it's being used. This can cause a brief power loss, which can change the measurement units, or change the code number used to program the meter to match a particular vial of test strips, or change the 14 to 30 day glucose average calculated by the meter.

LifeScan has issued a worldwide notification of users and healthcare professionals, and the company is including special instructions in each package of test strips.

Health professionals should remind patients to make sure that their meter's unit of measure is set to "mg/dL," each time they test. They should also confirm that the code number on the meter's display matches the code number on the test strip vial each time they test. Patients can call LifeScan Customer Service at
1-800-515-0915 to confirm that their meter is set to the proper measurement units.

Category:

News & Politics

Tags:

• LifeScan
• Blood
• Glucose
• Meters
• FDA
• OneTouch
• Ultra
• FastTake
• InDuo
• Measurements
• mg/dL
• Patient
• Safety