Home Diagnostics, Inc Blood Glucose Monitoring Systems Using GDH-PQQ
• TRUEresult
®
/ TRUEtest™ Blood Glucose Test Strips
• TRUE2go™ / TRUEtest™ Blood Glucose Test Strips
What causes these interferences?
The GDH-PQQ methodology does not distinguish between maltose, galactose,
xylose, and glucose when measuring blood glucose. Maltose, galactose, and xylose
are not normally found in the blood, but can be found with the administration of
certain drugs. When present in the blood, these substances can falsely increase the
blood glucose result to a clinically significant level. A false high glucose result may
lead to in inappropriate treatment, such as the injection of insulin, which could lead
to a hypoglycemic coma and death.
Actions required:
• Be aware of the drugs used (including any investigational drugs and
those made by compounding pharmacies) that contain or metabolize
maltose, galactose, or xylose,
• At patient admission/presentation and periodically throughout the
patient’s stay at the facility, assess the presence and use of therapies
containing interfering drugs,
• Consult with the pharmacist for more information on which drugs have
been or will be administered to the patient,
• Identify and flag files or records of at-risk patients,
• If there are pre-print orders sets for patients receiving interfering drugs,
include a prescription to test blood glucose using laboratory methods,
• Use only laboratory methods for monitoring blood glucose levels in
patients receiving interfering drugs,
• Establish facility protocols to verify point-of-care (bedside) blood
glucose results with laboratory results for patients who are unresponsive
or unable to communicate,
• Ensure that protocols for testing adequately address the issue when the
patient history is unknown,
• If your facility provides a blood glucose monitoring system for use at
home for an at-risk patient, instruct the patient not to use a blood glucose
monitoring system that utilizes GDH-PQQ, including the TRUE2go and
TRUEresult Systems,
• After drug treatment is completed, ensure that use of a blood glucose
monitoring system that utilizes GDH-PQQ is cleared by the Doctor or
Healthcare Professional before use.
File this Safety Notice for future reference.
Questions?
If you have any questions regarding the information contained in this Safety
Notice, please go to
www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm154213.htm.
or
call for assistance using the number on the front cover of the Manual.
TRUEresult
®
Quality Assurance / Quality Control Manual
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