Limitations of the procedure, Glucometer elite – Bayer HealthCare Elite XL User Manual

Page 30

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26

Glucometer Elite

®

XL

section

26

I3

1. PRESERVATIVES:

Fluoride – Do not use fluoride as a preservative for blood

specimens.

Iodoacetic acid – Do not use iodoacetic acid as a

preservative for blood specimens.

2. ARTERIAL SPECIMEN: Arterial specimens with pO

2

of

>200 mmHg had a small bias (average of –6%) on the
Glucometer Elite in comparison to the laboratory method
glucose results. The reference range for arterial pO

2

is 80 to

110 mmHg (11.04 to 14.36 kPa).

3. NEONATAL USE: The Glucometer Elite

®

XL System

is the only Glucometer Elite System qualified for neonatal
use. It is intended for monitoring treatment of hypo-
glycemia in neonates. The Glucometer Elite XL System
is not intended for diagnosis of neonates for hypoglycemia.
Do not use any other Glucometer Elite

®

Blood Glucose Meter

for neonatal testing.

4. METABOLITES: Reducing substances such as ascorbic acid

and uric acid at normal blood concentrations do not signifi-
cantly affect Glucometer Elite XL blood glucose test results.

5. HEMATOCRIT: At normal glucose levels, Glucometer Elite

Test Strip results are not significantly affected by hematocrits
in the range of 20% to 60%. At glucose levels above
300 mg/dL (16.7 mmol/L), hematocrit levels above 55% will
cause lowered results. For Neonatal Use: At glucose levels
between 20 mg/dL (1.1 mmol/L) and 120 mg/dL (6.7 mmol/L),
Glucometer Elite XL results are not significantly affected by
hematocrit levels in the range of 20% to 70%.

6. LIPEMIC SPECIMEN: Cholesterol up to 500 mg/dL

(13.0 mmol/L) or triglycerides up to 3000 mg/dL
(33.9 mmol/L) do not significantly affect the results.
Glucose values, however, in specimens beyond these
levels should be interpreted with caution.

CONTRAINDICATION (Bayer advises against): Capillary
blood glucose testing may not be clinically appropriate when
peripheral blood flow is decreased. Shock, severe hypotension,
hyperosmolar hyperglycemia and occurrence of severe dehydra-
tion are examples of clinical conditions which may adversely
affect the measurement of glucose in peripheral blood.

1

1

Atkin S, Jaker MA, Chorost MI, Reddy S, Fingerstick Glucose
Determination in Shock. Annals of Internal Medicine 1991,
114: 1020–24

Limitations of the Procedure

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