Inadvertent Unit of Measure Change on LifeScan Glucose Meters

Yael Waknine

Disclosures

May 12, 2005

May 12, 2005 — The U.S. Food and Drug Administration (FDA) and LifeScan, Inc. (a Johnson & Johnson company) have notified healthcare professionals and consumers worldwide of the potential for users of OneTouch Ultra, InDuo, and OneTouch FastTake glucose meters to accidentally alter the unit of measure while setting date and time, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting system. The inadvertent switch in units can result in misinterpretation of blood glucose results.

In addition, dropping a meter while in use can cause a brief interruption of power and an unexpected change in the unit of measure and/or the code number used to program the meter to match a particular vial of test strips.

In the period from early 2004 through mid-March 2005, the company has received 40 reports worldwide of glucose level misinterpretation leading to inappropriate management of diet and medication and temporary periods of hypo- or hyperglycemia, in some cases requiring medical attention.

The glucose meters were originally designed to allow consumers to select the units used to display results according to consumers' national standard. Blood glucose is usually measured in mg/dL in the U.S. while mmol/L is used in many other countries.

More than 4.7 million of these glucose meters have been distributed worldwide, primarily through retail pharmacy and mail order channels. In some countries, the FastTake device is sold under the EuroFlash, SmartScan, and PocketScan brand names.

Although consumers are encouraged to continue use of the devices, they are advised to confirm their glucose meter's unit of measure and code number at each testing according to instructions inserted in each test strip package.

According to the LifeScan letter, the company has stopped shipment until further notice of all glucose meters that allow switching of units by users. New OneTouch Ultra meters have been modified to prevent inadvertent switching and are expected to be ready for shipment by next week.

Further information regarding proper glucose meter use in the U.S. may be obtained by contacting LifeScan Customer Service at 1-800-515-0915. Contact information for other countries is available at https://www.LifeScan.com.

Physicians and consumers are encouraged to report adverse events related to use of the glucose meters to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch/report.htm, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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