Abbott is initiating a worldwide medical device correction for users of its Precision Xtra™, Optium™, ReliOn® Ultima, Rite Aid® and Kroger® blood glucose meters manufactured after January_31, 2007.
If the meter is dropped on a hard surface, part or all of the display screen may not work properly or may appear blank, which could result in an inability to view blood glucose test results.
The inability to generate blood glucose results could result in significant risk for hypoglycemia or hyperglycemia.
Users of these meters who note that the display screen is not working properly should immediately stop using their meter as referenced in the User Guide and call Abbott Diabetes Care customer care for assistance at 1-877-844-4404. Through internal testing, Abbott Diabetes Care has found that when recently produced meters are dropped onto a hard surface, part of the display can be jarred or disconnected, thereby making it difficult to read the lot number or date information, or causing the screen to appear blank. No injuries have been reported to date.
Patients should keep their glucose meters in the wallet provided to offer additional protection for the meter. If the meter is dropped on a hard surface, patients should immediately perform a meter display check. Instructions on how to do this are detailed in the meter’s Users Guide. If no problems are encountered during the automatic display check, the meter is ready for use. Customers may call Abbott Diabetes Care customer care at 1-877-844-4404 to determine the date their meter was manufactured. Customers may also call customer care if they have questions or need a replacement meter.
Precision Xtra™, Optium, ReliOn® Ultima, Rite Aid® and Kroger® blood glucose meters have been distributed via retail and mail order pharmacies, physician offices and distributors. Abbott is notifying physicians, pharmacists, distributors and registered users by letter.
Blood glucose test strips used with these meters are not affected by this notification.