McKesson TRUEresult User manual

QUALITY ASSURANCE AND
QUALITY CONTROL REFERENCE GUIDE
FOR MULTI-PATIENT USE FACILITIES
QUALITY ASSURANCE AND
QUALITY CONTROL REFERENCE GUIDE
FOR MULTI-PATIENT USE FACILITIES
Information in This Manual is Spe ifi for Health are Providers
ATTENTION:
TRUEtest™Strips ontain GDH-PQQ
enzyme. Please arefully review all riti al
safety information and instru tional
materials prior to performing patient
blood glu ose testing.
ATTENTION: RISK MANAGEMENT AND CHIEF MEDICAL OFFICER
www.ho ediagnostics.co
1-800-803-6025 or 1-954-677-4599.
© 2010 Home Diagno tic , Inc. TRUEre ult and TRUEte t are trademark of Home Diagno tic , Inc. E9SUN21 Rev. 3 • E9051-90

QUALITY ASSURANCE AND
QUALITY CONTROL REFERENCE GUIDE
FOR MULTI-PATIENT USE FACILITIES

TRUEresult®Quality Assurance / Quality Control Manual
1
Safety Notice
ATTENT ON: Pharmacy Staff, Nursing Staff, Laboratory Staff, and
Central Supply Staff – Reminder of Potential for Falsely
Elevated Blood Glucose Results due to Drug nterferences
This Safety Notice is for personnel involved in the issuance of point-of-care
blood glucose testing systems and personnel involved in actual point-of-care
blood glucose testing. Parenterally administered drugs containing or
metabolizing to maltose or galactose, and orally administered xylose can cause
falsely high blood glucose results with certain point-of-care blood glucose
monitoring systems that utilize the enzyme glucose dehydrogenase-PQQ
(G H-PQQ) for the measuring of a blood glucose result.
Please note: The interferences described in this Notice may be seen with all
blood glucose monitoring systems that use GDH-PQQ methodology, regardless
of the manufacturer of the system.
The information regarding the limitations of using G H-PQQ methodology may
or may not be included in the labeling of drugs containing or metabolizing
maltose, galactose, or xylose. It is important that all staff are aware of this
interference in order to prevent inappropriate treatment based on falsely elevated
blood glucose results. Staff must advise at-risk patients who use blood glucose
monitoring systems with G H-PQQ methodology of these risks and the
consequences of inappropriate treatment.
Who is at risk?
Patients at risk for falsely elevated blood glucose results include those using
blood glucose monitoring systems utilizing glucose dehydrogenase-PQQ, and
who are:
• Peritoneal dialysis patients receiving dialysis solutions containing
icodextrin (e.g. Extraneal®, Icodial®) that is metabolized to maltose;
• Receiving injections or infusions of solutions containing galactose or
maltose (including some human immunoglobulin preparations
(e.g. Octagam®, WinRho®, S F Liquid, HepaGam B™);
• Patients undergoing xylose absorption testing;
• Patients receiving intravenous solutions containing maltose as a
substitute for glucose or as a means for patient hydration;
• Patients receiving any drugs, including any investigational drugs and
those made by compounding pharmacies, which contain or metabolize
to maltose, galactose, or xylose (Orencia®, Adept®, Bexxar®).
Note: An At- isk Patient Identification Notice located under Forms, Section
10, in this Manual may be used for easy identification of at-risk
patients.

Home Diagnostics, nc Blood Glucose Monitoring Systems Using GDH-PQQ
• TRUEresult®/ TRUEtest™ Blood Glucose Test Strips
• TRUE2go™ / TRUEtest™ Blood Glucose Test Strips
What causes these interferences?
The G H-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 G H-PQQ, including the TRUE2go and
TRUEresult Systems,
• After drug treatment is completed, ensure that use of a blood glucose
monitoring system that utilizes G H-PQQ is cleared by the octor 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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TRUEresult®Quality Assurance / Quality Control Manual
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ntroduction
Home iagnostics, Inc (H I) is proud to present the TRUEresult Blood Glucose
Monitoring System, a no-coding system which means the Meter does not have to
be coded to each lot of test strips. The Quality Assurance/Quality Control
Manual is designed for use specifically by the Healthcare Professional for point-
of-care testing in a multi-patient, multi-user setting. Healthcare Professionals in
your facility now have a very simple and accurate way to safely test blood
glucose levels in your patients.
Home iagnostics, Inc. recognizes the importance of practicing safe and reliable
testing using the TRUEresult Blood Glucose Monitoring System. Therefore, this
Manual has been designed to provide the following:
• A basic understanding of the TRUEresult System,
• A detailed testing guide,
• Quality Control Program recommendations for the TRUEresult
System in your facility,
• A complete guide to troubleshooting issues and concerns that may
arise with using with the TRUEresult System in patient care,
• A comprehensive H I certified training program for Healthcare
Professionals that will be using the TRUEresult System.
CAUTION!
Please read this entire Manual and all product Instructions for Use before
testing. Operators of the T UEresult Blood Glucose Monitoring System must
be trained per the HD Training Certification Program, Section 9, prior to
using the product.
CAUTION!
DO NOT change patient medication, diet, or exercise routine without
consulting the patient’s Doctor or Diabetes Healthcare Professional.
Use of T UEresult in a manner not specified in this Manual is not
recommended and may affect the ability to determine true blood glucose levels.
Our goal is to provide quality healthcare products and dedicated customer
service. For questions about the TRUEresult products, visit our website at
www.homediagnostics.com.

TRUEresult®Quality Assurance / Quality Control Manual
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Table of Contents
Safety Notice...........................................................................................................................................1-2
ntroduction ...............................................................................................................................................3
Table of Contents ......................................................................................................................................4
Section 1: Using TRUEresult®in a Clinical Setting
Critical Safety Information/Important Information/Limitations/Expected Results ....................6-8
Regulatory Requirements - CLIA...................................................................................................9
Proficiency Testing Information ...................................................................................................10
Meter Specifications .....................................................................................................................11
Material Safety ata Sheets (MS S)......................................................................................12-17
Section 2: Description of System
Meter........................................................................................................................................19-20
TRUEtest™ Test Strips ...........................................................................................................20-21
TRUEtest Glucose Control Solution.............................................................................................22
Section 3: Quality Control Testing
Automatic Self-Test ......................................................................................................................24
Control Test...................................................................................................................................24
How to Perform a Control Test ...............................................................................................25-26
Section 4: Blood Glucose Testing
Sample Information .................................................................................................................28-29
Obtaining a Blood Sample............................................................................................................29
Tips for Fingertip Sampling....................................................................................................29
Tips for Forearm Sampling ...............................................................................................29-30
How to Perform a Blood Test..................................................................................................30-31
System Out of Range Warning Messages ....................................................................................31
Section 5: Set Up of Time, Date, Ketone Alert and Testing Reminders
Time/ ate......................................................................................................................................33
Ketone Alert..................................................................................................................................34
Testing Reminders ...................................................................................................................34-35
Exit Set Up....................................................................................................................................35
Section 6: Memory
Memory, Viewing Averages, Viewing Memory.....................................................................37-38
Section 7: Care and Storage of System
System (Meter and Test Strips) ....................................................................................................40
Meter .............................................................................................................................................40
TRUEtest Test Strips ....................................................................................................................40
TRUEtest Glucose Control Solution.............................................................................................40
Battery Replacement .....................................................................................................................41
Section 8: Troubleshooting
isplay Messages..........................................................................................................................43
isplay Messages..........................................................................................................................44
Section 9: Training Certification Program
Certificate Information ............................................................................................................46-47
Training Checklist ...................................................................................................................48-49
Training Written Test ..............................................................................................................50-54
Training Certificate (example)......................................................................................................55
Section 10: Forms
Quality Control Log.................................................................................................................57-58
At-Risk Patient Identification Notice ...........................................................................................59
Section 11: TRUEresult Lifetime Warranty
TRUEresult Lifetime Warranty ....................................................................................................61
Section 12: References
References .....................................................................................................................................63

Section 1:
Using TRUEresult®
in a Clinical Setting

TRUEresult®Quality Assurance / Quality Control Manual
Critical Safety nformation / mportant nformation / Limitations /
Expected Results
WA NING!
T UEtest Blood Glucose Test Strips utilize glucose dehydrogenase-PQQ
(GDH-PQQ). The T UEresult System MUST NOT be used for the following
patient conditions:
• Peritoneal dialysis patients receiving dialysis solutions containing
icodextrin (e.g. Extraneal®, Icodial®) that is metabolized to
maltose,
• Injection or infusion of solutions containing galactose or maltose,
including some human immunoglobulin preparations
(e.g. Octagam®, Win ho®, SDF Liquid, HepaGam B™),
• Patients undergoing xylose absorption testing,
• Patients receiving intravenous solutions containing maltose as a
substitute for glucose or as a means for patient hydration,.
• Any drugs, including any investigational drugs and those made by
compounding pharmacies, which contain or metabolize to maltose,
galactose, or xylose (Orencia®, Adept®, Bexxar®).
Using the T UEresult System for testing patients with the above conditions
may result in falsely high glucose results. A falsely elevated glucose result may
cause a patient or healthcare professional to take inappropriate steps to bring
the blood glucose in normal range, including giving insulin. The inappropriate
use of insulin could lead to unconsciousness, severe hypoglycemic coma and
possible death. More information may be found in the T UEtest Test Strip
Instructions for Use or at
www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm154213.htm1
Limitations
• Please read all product Instructions for Use carefully before
referencing or using this Manual.
• Use only TRUEtest Blood Glucose Test Strips and TRUEtest Glucose
Control Solution when testing with the TRUEresult Meter.
• Perform Glucose Control Tests before performing a blood glucose
test (See Quality Control Testing, Section 3), when using the System
for the first time. Three levels of TRUEtest Glucose Control Solution
are available for Quality Control Testing. Contact your distributor to
order different levels of Glucose Control Solution. We recommend
testing at least 2 levels of Control. For testing frequency and the
number of Control levels to test, refer to your facility quality control
procedure/policy.
• TRUEresult is an in vitro quantitative system that is used for self
testing and point-of-care testing of human whole blood only.
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TRUEresult®Quality Assurance / Quality Control Manual
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• The most accurate results are obtained using fresh, capillary whole
blood from the fingertip. Venous whole blood drawn in E TA
(purple top tube) or heparin (green top tube) may be used for testing.
Mix tube contents gently before using. Use venous blood within 30
minutes after drawing. Serum, clotted blood, or plasma cannot be
used with the TRUEresult System.
• Capillary blood from the forearm may be used. Check with the
octor or Healthcare Professional to see if forearm testing may be
used for glucose testing on the patient. Results from the forearm are
not always the same as results from the fingertip. Use fingertip
instead of forearm:
- Within 2 hours of eating, exercise, or taking insulin,
- If the patient’s blood glucose may be rising or falling rapidly or
their results often fluctuate,
- If the patient is ill or under stress,
- If the glucose result may be low or high,
- If symptoms of low or high glucose levels are not evident.2
• For evaluation or Quality Control procedures where TRUEresult
blood glucose values are compared to blood glucose values given by
a laboratory, it is recommended that capillary or venous whole blood
obtained from the same site be used for both the laboratory
instrument as well as the TRUEresult System. Laboratory tests should
be performed within 30 minutes of a blood glucose meter test to
minimize the changes in glucose values due to glycolysis. Results
from the TRUEresult System are considered accurate if within + 20%
of laboratory results. If patient has recently eaten, finger results
from the TRUEresult System can be up to 70 mg/dL higher than
venous laboratory results.3
• The TRUEresult System cannot be used in the diagnosis of diabetes
or to test blood glucose in neonates.
• Inaccurate results may occur in severely hypotensive patients or
patients in shock. Inaccurate results may occur for patients
experiencing a hyperglycemic-hyperosmolar state, with or without
ketosis. Critically ill patients should not be tested with a blood
glucose meter.4
• Testing at altitudes up to and including 10,150 feet will not affect
accurate results.5
• Hematocrit levels between 20% and 60% will not affect accurate
results.5

Expected Results
Each patient should have specific blood glucose target ranges that are
determined by the octor or iabetes Healthcare Professional. Having most
blood glucose results within the patient’s target range shows how well a
treatment plan is working to control glucose levels. Keeping results within the
patient’s target range helps slow or stop complications from diabetes.
Expected Results for people without diabetes6:
Plasma Blood Glucose Result
Before eating <126 mg/dL
Two hours after meals <200 mg/dL
• Low blood glucose (hypoglycemia) symptoms may include
trembling, sweating, intense hunger, nervousness, weakness or
trouble speaking.
• High blood glucose (hyperglycemia) symptoms may include intense
thirst, a need to urinate often, a dry mouth, vomiting, or headache.
If the patient is showing any of these symptoms, check their blood glucose. If
any result seems higher or lower than expected, repeat the test with a new Test
Strip. Contact the octor or iabetes Healthcare Professional with any unusual
results.
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