Blood Glucose Meter

Figure: Accu_Chek Active[3]

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 Blood Glucose Meter

INTENDED USE

A glucose meter (or glucometer) is a medical device for determining the approximate

concentration of glucose in the blood. It is a key element of home blood glucose
monitoring (HBGM) by people with diabetes mellitus or hypoglycemia.

Blood Glucose Meter is used for quantitative determination of blood glucose values in
fresh capillary blood using Accu-Chek Compact test strips. It is Suitable for self-testing.

The meter may be used by people with diabetes to test their own blood glucose as well
as for blood glucose determination by healthcare practitioners in a professional setting.

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PRINCIPLE OF WORKING

Most glucometers today use an electrochemical method. Test strips contain a capillary
that sucks up a reproducible amount of blood. The glucose in the blood reacts with an
enzyme electrode containing glucose oxidase (or dehydrogenase). The enzyme is
reoxidized with an excess of a mediator reagant, such as aferricyanide ion, a ferrocene
derivative or osmiumbipyridyl complex. The mediator in turn is reoxidised by reaction at
the electrode, which generates an electrical current. The total charge passing through
the electrode is proportional to the amount of glucose in the blood that has reacted with
the enzyme. The coulometric method is a technique where the total amount of charge
generated by the glucose oxidation reaction is measured over a period of time. This is
analogous to throwing a ball and measuring the distanceit has covered so as to
determine how hard it was thrown. The amperometric method is used by some meters
and measures the electrical current generated at a specific point in time by the glucose
reaction. This is analogous to throwing a ball and using the speed at which it is
travelling at a point in time to estimate how hard it was thrown. The coulometric method
can allow for variable test times, whereas the test time on a meter using the
amperometric method is always fixed. Both methods give an estimation of the
concentration of glucose in the initial blood sample.

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WORKING

Glucose meter systems are biosensors that operate on the following general scheme:

Glucose—Selective membrane—Enzyme layer—Transducer—Amplified, translated

screen printing.

Figure: Blood Glucose Meter Block Diagram[4]

In this scheme, glucose passes through a selectively permeable membrane controlling

the transport of analytes to a metabolizing enzyme system that generates a response
on interaction with the glucose, leading to an electrical signal generated by the
transducer and eventually amplified and translated into glucose concentration on the
meter screen. Each of these components is briefly described.

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The selective membrane

The selectively permeable membrane controls the flux of the solute by size and charge
exclusion and thus helps to control the operating range and reduces the impact of
sample matrix caused especially by the haematocrit. Data obtained by manipulation of
selective membranes have shown a strong supportive evidence of how the same
reaction chemistry such as that of glucose oxidase can be “refashioned” to extend
measurement versatility.

The enzyme layer

The enzymes used in glucose meters are oxidoreductases of which the lower-
polarizing-potential oxidases (+650 mV) are preferred to the higher-polarizing-potential
reductases (+800mV) which, as a result of high potential, are associated with surface
fouling and free-radical side reactions.

Transducer

Four principal transducer types currently used in glucose meters are:

Thermal transducer - measuring calories liberated or consumed during a chemical

reaction; optical transducer - measuring optical properties such as absorbance,
fluorescence, reflectance, or light scatter. electrical transducer - measuring
conductivity  and electrochemical transducer - measuring current out-put at fixed
voltage, a technique known as amperometry.

Amperometry has proved a decisive advantage in many comparative studies of modern

glucose meter systems , especially when polymeric polyelectrolyte sugars have been
used as an enzyme loader in the enzyme layer  to exclude background reducing
species such as ascorbates, urates and others found in clinical specimens. Moreover,
inclusion of electron shuttle molecules in the enzyme layer have reduced the working
electrode potential to <200mV thereby cutting off interferences such as tyrosine,
paracetamol, ascorbate, and urate , thus enabling the technique to be used both in
vitro and in vivo .

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Amplified, translated screen-printing

The measured signal is amplified, translated into glucose concentration and thereafter
screen-printed on the meter dial. The screen-printing technology enables bulk
manufacture with high precision and reproducibility resulting in low-cost electrodes for
single use only .

The selective membrane and the enzyme layer are normally combined to make the
glucose “strips” whereas the transducer and the amplifier screen-printer are integral
parts of the meter. Proprietary glucose strips matched with their appropriate meter
together make the glucose meter system each with its peculiar limitations in storage,
longevity, humidity and temperature ranges. Collation of these limitations on the glucose
meter systems used in this work was a cardinal goal.

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 Blood Glucose Meter

TECHNICAL SPECIFICATIONS

Meter type: Accu-Chek Active (Model GC).

Test principle: Determination of glucose in fresh capillary blood by
reflectance photometry.
If using other sample material, please refer to the package
insert that came with the Accu-Chek Active test strips.
Blood glucose concentrations may be tested in whole blood
or plasma. Although you always apply whole blood to the
test strip, your meter displays blood glucose results that
relate either to whole blood or to plasma. To see whether
your blood glucose meter displays results relating to whole
blood or to plasma,
see the package insert that came with your test strips.
There you will also find information on how the system
works, on the test principle and on reference
methods.

10–600 mg/dL (0.6–33.3 mmol/L)

Measuring range:

1–2 μL (1 μL (microlitre) = 1 thousandth of a millilitre)

Sample size:

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 Blood Glucose Meter

Measuring time: approx. 5 seconds if the test strip is in the meter when
blood is applied
(depends on concentration)
approx. 10 seconds if the test strip is outside the meter
when blood is applied
(depends on concentration).

Power supply 1 battery (type CR 2032)

Battery life approx. 1000 tests or approx. 1 year

Automatic power-off after 30 or 90 seconds depending on operating status

Memory 350 test results with time and date, as well as 7, 14 and 30
day averages
Temperature
during testing +10 to +40 °C
during storage -25 to +70 °C
without battery -10 to +50 °C
with battery

Atmospheric humidity up to 85 % relative humidity

during testing up to 93 % relative humidity
during storage
sea level to 4000 m
Altitude
104.5 × 51.5 × 22 mm

Dimensions

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Weight
without battery approx. 55 g
with battery approx. 60 g

Display 96-segment liquid crystal display (LCD)

Interface infrared port

Safety class III

LED/IRED Class 1

Electromagnetic This meter meets the electromagnetic immunity

compatibility requirements as per ISO 15197
Annex A. The chosen basis for electrostatic discharge
immunity testing was basic standard IEC 61000-4-2.
In addition, it meets the electromagnetic emissions
requirements as per EN 61326. Its electromagnetic
emission is thus low. Interference from other electrically
driven equipment is not to be anticipated .

Performance analysis The performance data for the Accu-Chek Active system
(Accu-Chek Active meter with Accu-Chek Active test strips)
was obtained using capillary blood from diabetic patients
(method comparison, accuracy), venous blood
(repeatability) and control solution (reproducibility). The
system is calibrated with venous blood containing various
glucose concentrations. The reference values for this were
obtained using the hexokinase method. For method

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comparison, the results were compared with results

obtained using the hexokinase method with deproteination
(automatic analyser). The hexokinase method is traceable
to a NIST standard.

The Accu-Chek Active system meets the ISO 15197 requirements.

RISK MANAGEMENT AND ASSESSMENT

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Incorrect results:
It can cause the wrong therapy recommendation to be made and so lead to serious
adverse health effects. Therefore, please follow the following instructions:-
 Only use the Accu-Chek Active meter with Accu-Chek Active test strips that are
approved by Roche Diagnostics GmbH. Other test strips deliver incorrect results.

 If the code number on the display does not match the code number on the test
strip container, do not perform blood glucose tests. Incorrect coding produces
incorrect results.

 Use only test strips with an expiry date which has not been exceeded. Test strips
with an expiry date that has already passed can produce incorrect results. If the

expiry date has passed, the symbol will be displayed in the test strip
symbol. Check the expiry date on the label of the test strip container. You will find

it next to the symbol. Also check that the current date is set in the meter
and that the inserted code chip belongs to the test strip you are using.

Coding:

Each time you open a new pack of test strips, you must replace the old code chip from
the meter with the new one from the pack. Code chips from other packs may contain
information that is incorrect for your new test strips, and can therefore lead to incorrect
test results. Incorrect results can cause the wrong therapy recommendation to be made
and so lead to serious adverse health effects.

Symbols seen and their meaning:

may indicate that your blood glucose is very low (possibly a severe
hypoglycemia). Follow the relevant instructions given by your doctor
immediately and repeat the test.
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The result is higher than 600 mg/dL (33.3 mmol/L).

The test strips are past their expiry date.

Evaluating results:

 If the displayed test result reflects the way you feel, continue as instructed by
your doctor. If the displayed test result does not reflect the way you feel, please
perform a performance check with an Accu-Chek Active control solution (see
Chapter 7). Repeat the blood glucose test afterwards. If the latest test result still
does not reflect the way you feel, please contact your doctor.
 Do not change your treatment based on just one result.

Testing blood glucose in more than one patient:

 Any patient with an infection or suffering from an infectious disease and any
patient who is a carrier of a multi-resistant microorganism must be assigned
his/her own meter. This also applies if it is suspected that a patient has one of
the above. During this time the meter must not be used to test any other patient.
 Patients and medical staff are potentially at risk of becoming infected if the same
Accu-Chek Active meter is used to test blood glucose in several patients. All
objects that come into contact with human blood are potential sources of
infection (see: Clinical and Laboratory Standards Institute: Protection of
Laboratory Workers from Occupationally Acquired Infections; Approved
Guideline – Third Edition; CLSI document M29-A3, 2005).
 Residues of water or disinfectant on the skin can dilute the drop of blood and so
produce incorrect results.

 Dispose of used lancets or disposable lancing devices and used test strips
according to the health and safety policy of your laboratory or institution.

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 Do not use results obtained at the limits of the permitted temperature range as a
basis for making therapeutic decisions, as they could be incorrect. Incorrect
results can cause the wrong therapy recommendation to be made and so lead to
serious adverse health effects.

Sources of interference:
 Strong electromagnetic fields may interfere with the proper operation of the
meter. Do not use the meter in close proximity to a strong electromagnetic field.
 To avoid electrostatic discharge, do not use the meter in a very dry environment,
especially one in which synthetic materials are present.

SAFETY ASPECTS

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 Blood Glucose Meter

Implausible results – possible sources of error:

If your meter repeatedly displays implausible results or error messages, please check
the following points. If your responses to the questions listed below are different from
those given, make the respective corrections when you perform the next test. If you
have taken all of these points into account and still obtain implausible results or error
messages, contact your customer support and service centre.

Error messages:

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PRODUCT LABELLING

Proprietary name: Accu-Chek Active System

Classification name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Classification: Class I

Product code: JJX, single (specified) analyte controls (assayed and unassayed).

Comparison with predicate:

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REGULATIONS AND STANDARDS

1. Regulation section: 21 CFR § 862.1660 Quality control material (assayed and

unassayed).
2. Panel: Clinical Chemistry (75).
3. The Accu-Chek Active system meets the ISO 15197 requirements.

This product fulfils the requirements of Directive 98/79/EC on in vitro

. diagnostic medical device.

This product fulfils the legal requirements of the People’s Republic of

China on the use of certain substances in electronic products.

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REFERENCES

1. https://www.accu-chek.com/us/logretriever.htm?urlString=cmV0cmlldmVyL3B1YmxpYy9
2. http://en.wikipedia.org/wiki/Glucose_meter

3. http://www.westerndiabetic.com/ACCU-CHEK-ACTIVE-METER-ONLY-5903184889001I.html

4. http://www.accessdata.fda.gov/cdrh_docs/pdf2/k021827.pdf

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