Download GDH-PQQ Test Strip Implementation Strategies

GDH-PQQ TEST STRIP IMPLEMENTATION STRATEGIES
The U.S. Food and Drug Administration (FDA) has provided
recommendations for using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) meters and contact information
to report any problems related to GDH-PQQ meter use. FDA
recommends the following:
—
—
Avoid using GDH-PQQ glucose test strips in healthcare
facilities.
—
Consider instituting drug interaction alerts in computer
order entry systems, patient profiles, and charts to alert staff
for the potential of falsely elevated glucose results.1
—
Periodically verify glucose meter results with laboratorybased glucose assays if using GDH-PQQ test strips in
patients who are not receiving interfering products.1
—
U.S. customers should report any GDH-PQQ glucose
monitoring technology problems to FDA’s MedWatch
Adverse Event Reporting program by telephone at (800)
332-1088; by fax at (800) 332-0178; by mail (using
postage-paid FDA Form 3500, available at http://www.
fda.gov/Safety/MedWatch/HowToReport/DownloadForms/
default.htm) at U.S. Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20852-9787; or online at
https://www.accessdata.fda.gov/scripts/medwatch/
medwatch-online.htm.2
If the facility uses the GDH-PQQ test strips, do not use
them on patients who are1 receiving interfering products,
including the following:
Extraneal (icodextrin) peritoneal dialysis solution
Some immunoglobulins: Octagam 5%, Gamimune
N5%,* WinRho SDF liquid, Vaccinia
Immune Globulin Intravenous (Human) and
HepaGamB
Adept adhesion reduction solution (4% icodextrin)
This last item is an additional patient safety suggestion for
hospitals that own GDH-PQQ devices. It is not an FDA
recommendation.
BEXXAR radioimmunotherapy agent
—
Orencia (abatacept)
Any product containing or metabolized into maltose,
galatose, or xylose
—
If unable to communicate information regarding concomitant medication use (e.g., with unresponsive patients,
patients that cannot communicate), use only laboratorybased glucose assays.
—
Verify upon admission, and periodically during their stay,
whether patients are receiving GDH-PQQ-meter-incompatible products.1
—
Educate staff and patients about the potential for falsely
elevated readings in the presence of certain nonglucose
sugars with GDH-PQQ glucose test strips.1
* Within the United States, Gamimune N 5% has not been manufactured
since December 2005, and no lots are in distribution in the United States.1
If your facility uses GDH-PQQ devices, place a label on
the device with a warning about not using the device on
patients receiving interfering products.
Notes
1. U.S. Food and Drug Administration (FDA). FDA public health
notification: potentially fatal errors with GDH-PQQ glucose
monitoring technology [online]. 2009 Aug 13 [cited 2011
Aug 3]. Available from Internet: http://www.fda.gov/
MedicalDevices/Safety/AlertsandNotices/
PublicHealthNotifications/ucm176992.htm.
2. U.S. Food and Drug Administration. GDH-PQQ (glucose
dehydrogenase pyrroloquinoline quinone) glucose monitoring
technology [MedWatch online]. 2009 Aug 13 [cited 2011
Aug 31]. Available from Internet: http://www.fda.
gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm177295.htm.