Public Advisory
April 19, 2005
Subject: LifeScan Announces Worldwide Correction Concerning Certain Blood Glucose Meters
Vancouver, B.C. – LifeScan, a maker of blood glucose testing systems for people with diabetes, is initiating a worldwide notification to all users of its OneTouch® FastTake® and InDuo® Meters and certain users of OneTouch® Ultra® Meters, that it may be possible for users to misinterpret their blood glucose results. All three affected meter systems were originally designed to allow patients to select one of two units of measure to display their test results- millimoles per liter (or “mmol/L“) or milligrams per deciliter (or “mg/dL“). This selection is typically determined by the standard used by the country in which patients live. LifeScan found that it was possible for patients, in the course of setting their meter’s date and time, to accidentally change the unit of measure and thereby misinterpret their blood glucose results.
In addition, very rarely, an event such as dropping a meter while in use can cause a brief power loss, which may also unexpectedly change the unit of measure and/or the code number used to program the meter to match a particular vial of test strips.
Users should continue to test their blood glucose, as the current meters provide accurate results when users confirm their unit of measure and code number before each test.
In Canada, LifeScan is offering to replace user-changeable versions of the OneTouch Ultra, InDuo, and OneTouch FastTake Meters, free of charge, with new meters that have been configured to prevent users from inadvertently changing the unit of measure.
LifeScan Canada began distributing non-user-changeable OneTouch Ultra Meters in August 2004. These non-user-changeable OneTouch Ultra Meters and the OneTouch® UltraSmart® Meters, which are also non-user changeable, do not need to be replaced in Canada.
To determine whether product replacement is necessary and to arrange for replacement, users of OneTouch Ultra, InDuo, and OneTouch FastTake Meters should call the LifeScan Meter Replacement Program line at 1-866-339-3045. LifeScan contact information, is also available at, www.onetouch.ca or in the Owner’s Booklets and test strip boxes corresponding to these products.
From the beginning of 2004 through mid-March 2005, LifeScan has received 40 worldwide reports of adverse events associated with these meters being set to the incorrect unit of measure. These events have generally consisted of temporary periods of high or low blood sugar, some of which required medical attention. An accidental change in the meter’s unit of measure can contribute to people with diabetes misunderstanding their test results and managing their diet or medication in a way that can result in temporary periods of high or low blood sugar. There are an estimated 4.7 million users of these products worldwide.
The company is conducting a worldwide notification program consisting of letters to registered users and healthcare professionals, and also special instructions inserted in each package of test strips. Patients with these products are advised to contact LifeScan to confirm their meter is set to the proper unit of measure.
To further address this issue, LifeScan has temporarily stopped shipment in Canada of the InDuo and OneTouch FastTake Meters that allow users to change the unit of measure. The timing to resume shipments of InDuo and OneTouch FastTake Meters has not been determined.
These meters are distributed worldwide primarily through retail pharmacies. Shipments of test strips for these meters are not affected.
LifeScan has notified Health Canada of this voluntary action.
LifeScan is a Johnson & Johnson company. For additional information and instructions on proper meter use, please visit www.onetouch.ca
