A Diagnostics & Imaging Week
LifeScan (San Jose, California), a maker of blood glucose test systems for diabetes, said it has launched "a worldwide notification" concerning its OneTouch Ultra, InDuo and OneTouch FastTake Meters, saying that users "may misinterpret their blood glucose results."
All three meters are designed to allow patients to select one of two units of measure to display test results, the selection typically determined by the standard used by the country where they live.
LifeScan said it is possible to accidentally change the unit of measure and thus result in misinterpretation of the results. In addition, it said, "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." The company said it is instructing patients to confirm their meter's unit of measure and the code number each time they test.
From early 2004 through mid-March 2005, LifeScan reported receiving 40 worldwide reports of adverse events as a result of meters set to the incorrect measures. The events, it said, generally consisted of temporary periods of high or low blood sugar, some requiring medical attention.
There are an estimated 4.7 million users of these products worldwide, LifeScan said, with the products distributed primarily through retail pharmacy and mail order channels. Test strips for these systems are not affected, it said.
The notification consists of letters to users and healthcare professionals, with instructions inserted in each test strip package and notification to the FDA and other regulatory agencies worldwide concerning the problem.
The company said it "temporarily" has stopped shipment of versions of the OneTouch Ultra, OneTouch FastTake and InDuo Systems that allow users to change the unit of measure, and is implementing a product modification for its new OneTouch Ultra Meters that will prevent users from inadvertently switching their meter's unit of measure.
It said shipments of the OneTouch Ultra Meters with this modification are expected to begin this week. It added that the timing to resume shipments of InDuo and OneTouch FastTake Meters has not been determined.