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Blood Glucose Test Strips

IMPORTANT

PLEASE READ THIS INFORMATION

AND THE EVENCARE G3 USER’S

GUIDE BEFORE USING EVENCARE G3

TEST STRIPS.

INTENDED USE

The EVENCARE G3 Blood Glucose Test Strips

are to be used with the EVENCARE G3 Blood

Glucose Meter; to quantitatively measure

glucose in capillary whole blood taken from

a fingertip, palm, or forearm. It is indicated

to be used for multiple patients in a clinical

setting by healthcare professionals, as an

aid to monitoring levels in Diabetes Mellitus.

This system should only be used with single-

use, auto-disabling lancing devices. It is not

indicated for the diagnosis or screening of

diabetes or for neonatal use.
• Users need to adhere to standard

precautions when handling or using this

device. All parts of the glucose monitoring

system should be considered potentially

infectious and are capable of transmitting

blood-borne pathogens between patients

and healthcare professionals. For more

information, refer to “2007 Guideline

for Isolation Precautions: Preventing

Transmission of Infectious Agents in

Healthcare Settings”, http://www.cdc.gov/

hicpac/2007ip/2007isolationprecautions.

html.

• The meter should be disinfected after

use on each patient. This blood glucose

monitoring system may only be used for

testing multiple patients when standard

precautions and the manufacturer’s

disinfection procedures are followed.

• Only auto-disabling, single-use lancing

devices may be used with this device.

The link of public health notification and

standard practice guideline are:
• “FDA Public Health Notification: Use of

Fingerstick Devices on More than One

Person Poses Risk for Transmitting

Bloodborne Pathogens: Initial

Communication” (2010)

http://www.fda.gov/MedicalDevices/

Safety/AlertsandNotices/ucm224025.htm

• “CDC Clinical Reminder: Use of Fingerstick

Devices on More than One Person

Poses Risk for Transmitting Bloodborne

Pathogens” (2010)

http://www.cdc.gov/injectionsafety/

Fingerstick-DevicesBGM.html

INTRODUCTION

The biosensor-based EVENCARE G3 Blood

Glucose Test Strip uses an enzyme to measure

blood glucose. The enzyme is specific for blood

glucose measurements from 20 to 600 mg/dL.

When blood touches the tip of the test strip,

it flows into the sampling end. The enzyme

reacts with glucose in the blood and produces

an electrical current. The meter measures

the current. The result appears on the screen

within six seconds.

REAGENT COMPOSITION

Each cm2 of test strip contains :
• Glucose Oxidase (A. niger) 2.3%
• Electron Shuttle

25%

• Non- Reactive Ingredients 72.7%

WARNINGS AND PRECAUTIONS

The EVENCARE G3 Blood Glucose Test

Strips are for use outside the body (in vitro

diagnostic use).
• DO NOT use test strips after their

expiration date.

• DO NOT use test strips that are wet

or damaged.

• DO NOT re-use the test strips.
• If a patient has symptoms that are not

consistent with their blood glucose test

results and you have eliminated common

procedural errors described in the User’s

Guide, call Medline Technical Support at

1-866-274-2131.

• Abnormal red blood cell counts

(hematocrits below 30% or above 55%) can

cause incorrect results.

• Never make major changes in patient’s

diabetes treatment program without

consulting their physician.

• Operating temperature for the meter and

the test strips is between 50˚F – 104˚F.

• Inaccurate results may occur in severely

hypotensive individuals or patients in

shock. Inaccurate low results may occur for

individuals experiencing a hyperglycemic-

hyperosmolar state, with or without

ketosis. Critically ill patients should not be

tested with blood

glucose meters.

• Inaccurate result may occur in individuals

who are dehydrated.

STORAGE AND HANDLING

1. Always close the vial cap tightly after

removing a test strip.

2. Store the test strips between 39˚F and

86˚F. Do not freeze.

3. Store out of direct sunlight.
4. When stored properly, unopened test strips

are stable until the expiration date printed

on the bottle.

5. Use within 6 months of first opening or

the expiration date on the label, whichever

comes first.

6. Do not handle the test strips with wet or

dirty hands.

SAMPLE COLLECTION AND

PREPARATION

The EVENCARE G3 Blood Glucose Test Strips

are designed specifically for use with fresh

capillary whole blood taken from a fingertip,

palm, or forearm. Testing must be performed

immediately after the sample is obtained.

Neonatal, plasma, or serum samples are not

validated and should not be used with the

EVENCARE G3 Blood Glucose Test Strips.

TEST PROCEDURE

See “Testing Blood Glucose” in the EVENCARE

G3 Blood Glucose Monitoring System User’s

Guide.

CLEANING PROCEDURE

See “Cleaning and Disinfecting Procedures” in

the EVENCARE G3 Blood Glucose Monitoring

System User’s Guide.

ALTERNATIVE SITE TESTING

You can also test from the palm and forearm.

This is called alternative site testing (AST). AST

results may differ from finger tip readings

(1)

DO AST ONLY in the following intervals:
• In a pre-meal or fasting state (more than

2 hours since the last meal).

• 2 hours or more after taking insulin.
• 2 hours or more after exercise.

Alternative site measurements should

never be used to calibrate continuous

glucose monitors (CGMs). Alternative site

measurements should never be used for

insulin dosing calculations.

Alternative Site Testing SHOULD NOT be used

when:
• Patients have hypoglycemic unawareness.
• Within 2 hours of a meal, exercise,

or medication.

•  Operating machinery or driving a car.
•  During times of stress.
•  Patient is ill.
•   Patient’s blood glucose is low.
•    Testing for hyperglycemia.
•    Patient’s routine glucose results are

often fluctuating.

EVENCARE

NOTE: If results from alternative site testing

do not agree with how the patient feels, use

fingertip testing instead.

EXPECTED VALUES

Blood glucose values obtained from

EVENCARE G3 Blood Glucose Test Strips

are calibrated to plasma equivalents. Blood

glucose values will vary depending on food

intake, medication, health, stress, and

exercise. The ideal ranges for adults without

diabetes are

(2)

• less than 100 mg/dL before meals.
• less than 140 mg/dL after meals.

QUALITY CONTROL

Follow instructions in the EVENCARE G3

Blood Glucose Monitoring System User’s

Guide. Do control tests when:
• Using the meter for the first time.
• Using a new bottle of EVENCARE G3

Blood Glucose Test Strips.

• At least once per week to verify that

the meter and test strips are working

properly together.

•  The test strip bottle is left open.
•  The meter is dropped.
•  You suspect the meter and test strips are

not working properly together.

• A patient’s test results do not agree with

how they feel.

• A patient’s readings appear to be

abnormally high or low.

• Test strips have been exposed to

a condition outside the specified

storage conditions.

• Practicing your testing technique.

Use only EVENCARE G3 Glucose Control

Solutions. Control solution test results should

fall within the control ranges printed on the

test strip bottle. Repeat control solution

testing if results fall out of range. Results may

fall out of range due to:
•  Errors in control solution testing procedure.
•  Expired or contaminated control solution.
•  Test strip is damaged.
•  Meter malfunction.

If the results still fall outside of control ranges,

please call Medline Technical Support at

1-866-274-2131 for help.

TROUBLESHOOTING

1. Confirm the test strips are not expired.
2. Make sure the blood fills the sampling

end of the test strip. If there is too little

blood, DO NOT add a second drop of blood.

Discard the test strip and retest with a new

test strip.

3. Check the system with control solution.
4. Refer to “Troubleshooting” in the

EVENCARE G3 Blood Glucose Monitoring

System User’s Guide.

If the issue continues, call Medline Technical

Support at 1-866-274-2131.

LIMITATIONS

• DO NOT use neonatal, plasma, or

serum samples.

• Altitudes up to 10,000 feet will not affect

test results.

• Hematocrit range: 30% – 55%.
• Triglyceride levels up to 500 mg/dL

have no significant effect on test results.

Levels above 2000 mg/dL may give falsely

low test results (normal range: 36 – 165

mg/dL).

• Ldopa levels above 1.5 mg/dL may cause

falsely high test results. People taking

this drug should consult their medical

professional if they are taking high doses of

Ldopa.

• Ibuprofen levels above 40 mg/dL may give

falsely high test results (therapeutic range:

1 – 7 mg/dL).

• Tolazamide levels above 60 mg/dL may

give falsely low test results (therapeutic

level: 23 mg/dL).

• Ascorbic acid levels above 5 mg/dL may

give falsely high test results (therapeutic

range: 0.4 – 2 mg/dL).

• Fructose levels above 15 mg/dL may give

falsely high test results (endogenous range:

1 – 6 mg/dL).

• Uric acid levels above 15 mg/dL may give

falsely high test results (normal range:

2.4 – 8 mg/dL).

• Cholesterol levels above 400 mg/dL may

give falsely high test results (reference

range: 114 – 201 mg/dL).

• Unconjugated bilirubin levels above

15 mg/dL, and conjugated bilirubin levels

above 25 mg/dL, may give falsely high

test results (normal ranges: unconjugated

bilirubin: 0.3 – 1.2 mg/dL; conjugated

bilirubin: 0 – 0.3 mg/dL).

• Icodextrin and its metabolites (maltose,

maltotriose and maltotetraose) do not

significantly affect test results.

• Methyldopa will not affect test results in

therapeutic range (1 – 7.5 mg/dL).

PERFORMANCE

EVALUATION DATA
Accuracy:

Total of 120 fingertip blood samples were

collected. Twenty-two (22) samples were from

glucose levels below 75 mg/dL. Ninety-eight

(98) samples were above or equal to

75 mg/dL. A total of 111 fresh blood samples

were collected from the palm and forearm.

Fourteen (14) samples were below 75 mg/dL,

and ninety-seven (97) samples were above

or equal to 75 mg/dL. Fingertip and alternate

site samples were tested by healthcare

professionals. Blood was tested on the

YSI 2300 Blood Glucose Analyzer as a

reference test.

Precision:

Three lots of EVENCARE G3 Blood Glucose

Test Strips were used for the precision study.

Venous blood in heparin-tubes was spiked to

5 concentrations. Blood glucose readings were

recorded for 20 days with 200 data points at

each level.

REFERENCES:

1. Shu M, Osamu F, Kazuhiro H, Yoshihito A: Hypoglycemia Detection
Rate Differs Among Blood Glucose Monitoring Sites. Diabetes Care
28(3):708–709, 2005
2. American Diabetes Association Position Statement: Standards of
Medical Care in Diabetes—2010. Diabetes Care 2010; 33 (Suppl.1):S11–
S61.

www.medline.com

Medline and EVENCARE are registered

trademarks of Medline Industries, Inc.

Manufactured in Taiwan for Medline

Industries, Inc., Mundelein, IL 60060 USA

Technical Support: 1-866-274-2131

(8:00 am – 5:00 pm CT / Monday – Friday)

To Reorder: 1-800-MEDLINE

RH16APB U.S. Patent # 7,655,128.

MPH3550

Table 2. Accuracy for blood glucose concentration ≥ 75 mg/dL

Sample Source