LifeScan, a maker of blood glucose meters for people with diabetes, says users of its OneTouch Ultra, InDuo, and OneTouch FastTake Meters may misinterpret their blood glucose results.
In some countries, the FastTake Meter is sold under the EuroFlash, SmartScan, and PocketScan brand names.
All three blood glucose meters let patients select one of two units of measure to display their test results, says LifeScan. The two units of measure are milligrams per deciliter (mg/dL), which is used in the U.S., and millimoles per liter (mmol/L), which is used in many other countries.
Source of the Problem
While setting the blood glucose meter's date and time, consumers could accidentally switch the unit of measure and thereby misinterpret their test results, says LifeScan.
"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," says LifeScan.
"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," says the company.
What to Do
Users should continue to test their blood glucose, says LifeScan. The company is instructing patients to confirm their blood glucose meter's unit of measure and the code number each time they test.
Letters will be sent to registered users of the blood glucose meters and to health care professionals. Special instructions will also be inserted in each package of test strips, but test strips are not affected, says LifeScan.
Patients with these blood glucose meters are advised to contact LifeScan Inc., to confirm their meter is set to the proper unit of measure. Patients in the U.S. can call LifeScan Customer Service at (800) 515-0915; contact information for other countries is available through the company's web site, says LifeScan.
Worldwide Notification, Shipments Suspended
LifeScan voluntarily issued a worldwide notification about the problem and says it has temporarily stopped shipments of the affected models. The company says it's modifying its new OneTouch Ultra Meters to prevent users from inadvertently switching their meter's unit of measure.
Shipments of the modified OneTouch Ultra Meters are expected to begin next week; shipments of the other models have not been determined, says LifeScan.
Reported Blood Glucose Meter Problems
LifeScan says it has received 40 worldwide reports of adverse events associated with these blood glucose meters being set to the incorrect unit of measure from the beginning of 2004 through mid-March 2005.
"These events have generally consisted of temporary periods of high or low blood sugar, some of which required medical attention," says LifeScan.
These blood glucose meters have an estimated 4.7 million users worldwide and are mainly distributed through retail pharmacies and mail order channels, says LifeScan.
SOURCES: News release, LifeScan.