FDA Reminders For Falsely Elevated Glucose Readings From Use of
Inappropriate Test Method
Intended Audience
All personnel performing glucose monitoring
Pharmacists
This is to remind you of the potential for death or serious injury
from treatment based on falsely elevated glucose readings from a
glucose dehydrogenase-based test method that is used to monitor
diabetic patients receiving parenteral drug products containing
maltose or galactose, or oral xylose. Recommendations for avoiding
this problem are provided below.
What’s the problem?
We recently received a report of a patient who suffered irreversible
brain damage following an aggressive insulin treatment that was
given for elevated glucose readings. Unfortunately, the elevated
glucose readings were incorrect because the glucose monitoring device,
which was unable to distinguish between glucose and maltose, was
reacting to the maltose in the intravenous immunoglobulin solution
that the patient was receiving.
Serious injuries and deaths from these false glucose readings continue
to occur despite this problem being discussed widely in the literature
and identified in the Clinical Laboratories Standards Institute
document titled, Glucose Monitoring in Settings Without Laboratory
Support; Approved Guideline (AST 4-A2).
What are the different glucose test methods?
Self-monitoring glucose devices used by diabetics at home and in
point-of-care settings, and laboratory glucose assays all use one
of the following test methods: glucose dehydrogenase pyrroloquinolinequinone
(GDH- PQQ), glucose dehydrogenase nicotinamide adenine dinucleotide
(GDH-NAD), glucose oxidase, or glucose hexokinase.
The test method is clearly marked in the device labeling/operator’s
manual.
The glucose monitoring systems that use the GDH-PQQ method
cannot distinguish the sugars glucose, maltose, galactose or xylose
from each other. The GDH-PQQ method may provide higher readings
in the presence of any of these sugars.
Glucose monitoring systems that use GDH-NAD, glucose oxidase,
or glucose hexokinase methods are not affected by the presence
of maltose, galactose or xylose.
What kinds of medical products may induce the falsely high
readings?
Medical products such as intravenous immunoglobulin solutions,
oral xylose, and peritoneal dialysis solutions may contain or be
metabolized to maltose, galactose or xylose.
Recommendations
To help prevent false glucose readings due to the limitations of
the glucose monitoring systems, personnel performing glucose monitoring
should:
- Know whether their glucose testing method uses GDH-PQQ, GDH-NAD,
glucose oxidase, or glucose hexokinase to measure the sugar level.
(The testing method is specified in the device operating manual
and is obtainable from the device manufacturer.)
- Use only GDH-NAD, glucose oxidase or glucose hexokinase
methods if the patient has received intravenous immunoglobulin
solutions within the last 24 hours, taken oral xylose within the
last 24 hours, or is on peritoneal dialysis.
Reporting to FDA
If you suspect that a death or serious injury was related to false
glucose readings, you should follow the mandatory reporting procedure
established by your hospital or user facility.
For events that did not result in death or serious injuries, you
can report directly to the device manufacturer or to MedWatch, the
FDA’s voluntary reporting program. MedWatch can be contacted
by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to
MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20852-9787; or online at http://www.fda.gov/medwatch/report.htm.
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