Technical Information - Bayer HealthCare Contour Next Link 2.4 User Manual

Symptoms of High or Low Blood Sugar
You can better understand your test results by being aware of the symptoms of high or low
blood sugar. Some of the most common symptoms are:
Low blood sugar
(Hypoglycaemia):
• Shakiness • Frequent Urination
• Sweating • Excessive Thirst
• Fast Heartbeat • Blurred Vision
• Blurred Vision • Increased Fatigue
• Confusion • Hunger
• Passing Out
• Irritability
• Seizure
• Extreme Hunger
• Dizziness
If you are experiencing any of these symptoms, test your blood sugar. If your
test result is under 2.8 mmol/L or above 13.9 mmol/L, contact your health care
professional immediately.
For additional information and a complete list of symptoms, contact your health
care professional.
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High blood sugar
Ketones (Ketoacidosis):
(Hyperglycaemia):
• Shortness of Breath
• Nausea or Vomiting
• Very Dry Mouth
WARNING

Technical Information

Accuracy
The C ® N LINK 2.4 blood glucose monitoring system was tested in 100 capillary
ONTOUR EXT
blood samples using 600 C ® N test strips. Two replicates were tested with each
ONTOUR EXT
of 3 lots of C N test strips for a total of 600 readings. Results were compared to
ONTOUR EXT
the YSI ® glucose analyzer, which is traceable to the CDC hexokinase method.
below compare the performance of the two methods.
Table 1 — System accuracy results for C
ONTOUR
C N test strips at glucose concentration < 4.2 mmol/L
ONTOUR EXT
Within +/– Within +/–
0.28 mmol/L 0.56 mmol/L
65 / 78 75 / 78
(83.3%) (96.2%)
Table 2 — System accuracy results for C
ONTOUR
C N test strips at glucose concentration ≥ 4.2 mmol/L
ONTOUR EXT
Within +/– 5% Within +/– 10%
396 / 522 517 / 522
(75.9%) (99.0%)
Acceptance criteria in ISO 15197: 2003 are that 95% of all differences in glucose values
(i.e., between reference method and meter) should be within +/-0.83 mmol/L for glucose
values less than 4.2 mmol/L, and within +/- 20% for glucose values greater than or equal to
4.2 mmol/L.
Precision
A repeatability study was conducted with the C ONTOUR
monitoring system using 5 venous whole blood specimens with glucose levels from
2.2 to 18.5 mmol/L. Multiple replicates (n=100 per lot) were tested using multiple
C N LINK 2.4 blood glucose meters and 3 lots of C
ONTOUR EXT
following precision results were obtained.
System repeatability results for C N
ONTOUR EXT
test strips
Mean Glucose Level, Standard Deviation,
mmol/L mmol/L
2.20 0.04
4.48 0.06
6.79 0.09
11.37 0.16
18.34 0.25
8 The tables
N LINK 2.4 meter using
EXT
Within +/–
0.83 mmol/L
78 / 78
(100%)
N LINK 2.4 meter using
EXT
Within +/– 15% Within +/– 20%
522 / 522 522 / 522
(100%) (100%)
N EXT LINK 2.4 blood glucose
N test strips. The
ONTOUR EXT
LINK 2.4 meter using C N
ONTOUR EXT
Coefficient of Variation
(%)
2.0
1.3
1.3
1.4
1.4
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