A Medical Device Daily

LifeScan (Milpitas, California), a maker of blood glucose testing systems, reported that it is initiating a worldwide notification to all users of its OneTouch Ultra, InDuo and OneTouch FastTake 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. This selection is typically determined by the standard used by the country in which they live.

LifeScan, a Johnson & Johnson (New Brunswick, New Jersey) subsidiary, found that it was possible for consumers, 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.

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.

In the U.S., milligrams per deciliter (mg/dL) is the standard of measure for blood glucose testing systems. In many other countries, millimoles per liter (mmol/L) is used.

The company said that users should continue to test their blood glucose but is instructing patients to confirm their meter’s unit of measure and the code number each time they test.

It also 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 the company to confirm their meter is set to the proper unit of measure.

LifeScan said it has notified the FDA and other regulatory agencies around the world of this voluntary action.

The products are distributed worldwide, primarily through retail pharmacy and mail-order channels. The FastTake meter is sold under the EuroFlash, SmartScan and PocketScan brand names. Shipments of test strips for these systems are not affected, the company said.

From the beginning of 2004 through mid-March of this year, LifeScan said it 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.

According to the company, there are an estimated 4.7 million users of these products worldwide.

To further address this issue, LifeScan reported that it has temporarily stopped shipment of versions of the OneTouch Ultra, OneTouch FastTake and InDuo systems that allow users to change the unit of measure. It is implementing a product modification for new OneTouch Ultra Meters that will prevent users from inadvertently switching their meter’s unit of measure. Shipments of the meters with this modification are expected to begin this week.

The timing to resume shipments of InDuo and OneTouch FastTake meters has not been determined.