April 2006
LifeScan blood-glucose monitors
Problems have emerged with two top-rated blood-glucose monitors, which were listed in our August 2005 blood-glucose monitors report (available to ): LifeScan’s OneTouch UltraSmart and OneTouch Ultra. Two other LifeScan models may also be problematic. With the OneTouch Ultra, OneTouch FastTake, and InDuo models, users can inadvertently change the unit of measure when setting the date and time. Dropping the meter may also change the unit or test-strip code number. With the OneTouch UltraSmart, the instructions incorrectly say that a low-blood-glucose warning message starts to appear at a higher threshold than it actually does. Also, a diagram incorrectly shows the upper arm as a potential site for drawing blood.
Products: Approximately 6 million OneTouch Ultras, InDuos, and OneTouch FastTakes (also sold abroad as EuroFlash, SmartScan, and PocketScan). As of mid-March 2005, LifeScan had received 40 reports of adverse events resulting from the problem, usually high or low blood sugar, sometimes requiring medical attention. LifeScan has stopped making all meters with that flaw and is now shipping a modified OneTouch Ultra. There’s a white label on the battery-compartment door of the discontinued OneTouch Ultra, a blue label on the modified one. Concerning the OneTouch UltraSmart, LifeScan has corrected the instructions and diagram.
What to do: For the OneTouch Ultra, OneTouch FastTake, and InDuo, check the unit of measure and the code number each time you test. For the OneTouch UltraSmart, go to www.lifescan.com, click on “Urgent Medical Device Correction,” print the letter, and keep it with the instructions. Contact LifeScan at 800-227-8862 or customerservice@lifescan.com, or go to www.lifescan.com.
Problems have emerged with two top-rated blood-glucose monitors, which were listed in our August 2005 blood-glucose monitors report (available to ): LifeScan’s OneTouch UltraSmart and OneTouch Ultra. Two other LifeScan models may also be problematic. With the OneTouch Ultra, OneTouch FastTake, and InDuo models, users can inadvertently change the unit of measure when setting the date and time. Dropping the meter may also change the unit or test-strip code number. With the OneTouch UltraSmart, the instructions incorrectly say that a low-blood-glucose warning message starts to appear at a higher threshold than it actually does. Also, a diagram incorrectly shows the upper arm as a potential site for drawing blood.
Products: Approximately 6 million OneTouch Ultras, InDuos, and OneTouch FastTakes (also sold abroad as EuroFlash, SmartScan, and PocketScan). As of mid-March 2005, LifeScan had received 40 reports of adverse events resulting from the problem, usually high or low blood sugar, sometimes requiring medical attention. LifeScan has stopped making all meters with that flaw and is now shipping a modified OneTouch Ultra. There’s a white label on the battery-compartment door of the discontinued OneTouch Ultra, a blue label on the modified one. Concerning the OneTouch UltraSmart, LifeScan has corrected the instructions and diagram.
What to do: For the OneTouch Ultra, OneTouch FastTake, and InDuo, check the unit of measure and the code number each time you test. For the OneTouch UltraSmart, go to www.lifescan.com, click on “Urgent Medical Device Correction,” print the letter, and keep it with the instructions. Contact LifeScan at 800-227-8862 or customerservice@lifescan.com, or go to www.lifescan.com.
