McKesson TRUEresult Manuale utente

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.

QUALITY ASSURANCE AND

QUALITY CONTROL REFERENCE GUIDE

FOR MULTI-PATIENT USE FACILITIES

TRUEresult®Quality Assurance / Quality Control Manual

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

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

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.

TRUEresult®Quality Assurance / Quality Control Manual

• 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.

TRUEresult®Quality Assurance / Quality Control Manual

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