DO NOT use TRUEresult®, TRUE2go® or TRUEtest™ products for patients receiving the following treatments:

• Peritoneal dialysis using solutions containing icodextrin (Extraneal®, Icodial®) that is metabolized to maltose,

• Injections or infusions of solutions containing galactose or maltose, including some human immunoglobulin preparations (Octagam® 5%, WinRho® SDF Liquid, or HepaGam B™),

• Xylose absorption testing,

• Intravenous solutions containing maltose,

• Any drugs that contain or metabolize to maltose, galactose, or xylose (Orencia®, ADEPT® or BEXXAR®).

Using TRUEresult®, TRUE2go® or TRUEtest™ products when receiving the above treatments may cause false high glucose results. False high results may lead to inappropriate therapy, which may result in coma or death. For more information:
http://wayback.archive-it.org/7993/20170111190502/http:/fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm

Safe Practice Recommendations for Healthcare Professionals:

• At patient admission/presentation and periodically throughout the patient’s stay at the facility, assess the presence and use of therapies containing interfering drugs (see above).

• Use only laboratory methods for monitoring blood glucose levels in patients receiving interfering drugs.

• If there are pre-print order sets for patients receiving interfering drugs, include a prescription to test blood glucose using only laboratory methods.

• Establish facility protocols to verify point-of-care (bedside) blood glucose results with laboratory results for patients who are unresponsive or unable to communicate.