LifeScan Inc. is notifying users that it is possible to accidentally change the measurement units on its OneTouch Ultra, InDuo, and OneTouch FastTake blood glucose meters, which can lead patients to misinterpret their results.
The company has found that users can inadvertently change the unit of measurement in the course of setting their meter's time and date. The two possible units on the affected meters are mg/dL and mmol/L.
The choice of measurement unit is generally determined by the country where the patient lives, and mg/dL is usually used in the United States.
About 40 adverse events worldwide related to incorrect measurement settings on these meters have been reported to LifeScan.
Most of the adverse events consisted of temporary periods of low or high blood glucose.
Patients using the affected meters are advised to contact the company to confirm that their meter is set to the proper unit of measurement. Users may contact LifeScan customer service by calling 800-515-0915.
For more information, see the Food and Drug Administration's firm safety alert at www.fda.gov/oc/po/firmrecalls/lifescan04_05.html