On December 7, the FDA sent a warning letter to LifeScan, Inc. concerning possible incorrect measurements on its blood glucose monitors. The letter was posted on the FDA's site on December 20. You can read it here.The letter was a culmination of correspondence between LifeScan and the FDA which began in April when the FDA sent inspectors to LifeScan's California plant. Shortly after that inspection began, LifeScan posted a press release discussing possible issues with its meters:
If you use a OneTouch® Ultra®, OneTouch® FastTake®, InDuo®, EuroFlash®, or SmartScan® Meter, we want to make you aware of two possible issues regarding these products.- LifeScan Press Release, April 14, 2005
- Your meter is designed to show results in two different units of measure. When setting your meter's date and time, it is possible for you to accidentally change the unit of measure.
- Very rarely, an event such as dropping your meter while in use can cause a brief power loss. As a result, the meter may unexpectedly change the unit of measure and/or the code number.
If you'd like to check your meter, visit LifeScan's site for more information including correct device settings. You'll find a list of contact phone numbers and an email response form there too.
For the FDA's warning letter:
LifeScan, Inc. Warning Letter
For LifeScan's page on how to check your meter:
URGENT: MEDICAL DEVICE CORRECTION -- OneTouch® Ultra®, OneTouch® FastTake®, InDuo®, EuroFlash® and SmartScan®
Some news summaries:
FDA Warns About Faulty Blood Sugar Monitors
FDA Warns Maker of Blood-Sugar Monitors
