Public Message on LifeScan Blood Glucose Meters

(posted June 13, 2005)

LifeScan has notified users of some of the company's blood glucose monitoring systems that it may be possible for them to misinterpret their blood glucose test results if their meter is set incorrectly. The affected meters are the OneTouch® Ultra®, the OneTouch® FastTake® and the InDuo® Systems.

These meters were originally designed to allow the patient to select one of two units of measure to display their blood glucose results: milligrams per deciliter (mg/dL), the standard used in the U.S., and millimoles per liter (mmol/L), which is used in many other countries. This feature allows patients to see their test results in the units customarily used in their own country. Meters with this same feature are also made by other companies.

LifeScan found that it was possible for patients, in the course of setting the meter’s date and time, to accidentally change the unit of measure. If the meter is in the wrong units of measure and the patient looks only at the result registered on the meter, without reading the measurement unit displayed next to the result, he or she could misunderstand the test result. This could lead to the patient managing his or her diet or medication in a way that could result in temporary periods of high or low blood sugar, which may require medical intervention.

Very rarely, an event such as dropping the meter while it is 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 strips.

Populations particularly vulnerable to the potential risk associated with misinterpreting their blood glucose results include pregnant women (in whom short term loss of blood sugar control may affect both maternal and fetal well-being), children, and geriatric patients (in whom visual and dexterity problems could increase the likelihood of accidentally changing the unit of measure and misinterpreting their results).

LifeScan no longer manufactures OneTouch Ultra, OneTouch FastTake and InDuo Meters that allow users to inadvertently change the unit of measure. However, many of these meters are still in use in the United States. To help educate patients and prevent further confusion in using these meters, LifeScan has undertaken a worldwide program to notify users and healthcare professionals about the issue. This notification included letters to patients and healthcare professionals as well as special instructions included in each package of the test strips that are used with the meters. Patients in the United States are being notified to be sure that their meter’s unit of measure is set to "mg/dL" each time they test, and that the code number on the meter's display matches the code number on the test strip vial each time they test.

FDA believes that most patients are capable of understanding and following these instructions and, thus, they can continue to use the meters safely. For this reason, it is not necessary for users to return the meters, and they are not being withdrawn from the market. However, for those patients who request it, the company is offering to replace the affected meters with a newer model that does not allow the user to inadvertently change the unit of measure.