CONTOUR NEXT LINK 2.4 - Technical Information

57
TECHNICAL
& CARE
Table 2 — System accuracy results for glucose concentration ≥ 75 mg/dL
Within ± 5% Within ± 10% Within ± 15% Within ± 20%
145 of 209 (69.4%) 196 of 209 (93.8%) 206 of 209 (98.6%) 209 of 209 (100%)
Analytical Accuracy
The CONTOUR NEXT LINK 2.4 blood glucose monitoring system was tested in 100 capillary
blood samples using 600 C
ONTOUR
®
NEXT test strips. Two replicates were tested with each
of 3 lots of C
ONTOUR NEXT test strips for a total of 600 readings. Results were compared
to the YSI glucose analyzer, which is traceable to the CDC hexokinase method. The tables
below compare the performance of the 2 methods.
Table 3 — System accuracy results for glucose concentration < 100 mg/dL
Accuracy
Table 1 — System accuracy results for glucose concentration < 75 mg/dL
Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL
5 of 9 (55.6%) 9 of 9 (100%) 9 of 9 (100%)
Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL
160 of 186 (86.0%) 183 of 186 (98.4%) 186 of 186 (100%)
Table 4 — System accuracy results for glucose concentration ≥ 100 mg/dL
Within ± 5% Within ± 10% Within ± 15%
307 of 414 (74.2%) 411 of 414 (99.3%) 414 of 414 (100%)
Table 5 — System accuracy results for glucose concentrations between 37 mg/dL
and 478 mg/dL
Within ± 15 mg/dL or ±15%
600 of 600 (100%)
Technical Information
User Accuracy
User accuracy criteria require that 95% of all differences in glucose values (i.e., between
reference method and meter) should be within ±15 mg/dL for glucose values less than
75 mg/dL, and within ±15% for glucose values greater than or equal to 75 mg/dL.
The CONTOUR
®
NEXT LINK 2.4 blood glucose monitoring system was tested in a user
performance study by 218 people with diabetes using capillary blood samples and
3C
ONTOUR NEXT test strip lots. The results were compared to the YSI
®
glucose analyzer
laboratory reference method, traceable to the CDC hexokinase method.
8
The tables below
show how well the 2 methods compared.
85587269_CntrNextLINK_2_4_UG_EN_FpBp_v4.indd 57 11/18/16 9:03 AM
TECHNICAL
& CARE
56
WARNING
If you are experiencing any of these symptoms, test your blood sugar. If your
test result is under 50 mg/dL or above 250 mg/dL, contact your health care
professional immediately.
For additional information and a complete list of symptoms, contact your health
careprofessional.
®
Symptoms of High or Low Blood Sugar
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
(Hypoglycemia):
High blood sugar
(Hyperglycemia):
Ketones (Ketoacidosis):
• Shakiness
• Sweating
• Fast Heartbeat
• Blurred Vision
• Confusion
• Passing Out
• Irritability
• Seizure
• Extreme Hunger
• Dizziness
• Frequent Urination
• Excessive Thirst
• Blurred Vision
• Increased Fatigue
• Hunger
• Shortness of Breath
• Nausea or Vomiting
• Very Dry Mouth
85587269_CntrNextLINK_2_4_UG_EN_FpBp_v4.indd 56 11/18/16 9:03 AM
57
TECHNICAL
& CARE
Table 2 — System accuracy results for glucose concentration ≥ 75 mg/dL
Within ± 5% Within ± 10% Within ± 15% Within ± 20%
145 of 209 (69.4%) 196 of 209 (93.8%) 206 of 209 (98.6%) 209 of 209 (100%)
Analytical Accuracy
The CONTOUR NEXT LINK 2.4 blood glucose monitoring system was tested in 100 capillary
blood samples using 600 C
ONTOUR
®
NEXT test strips. Two replicates were tested with each
of 3 lots of C
ONTOUR NEXT test strips for a total of 600 readings. Results were compared
to the YSI glucose analyzer, which is traceable to the CDC hexokinase method. The tables
below compare the performance of the 2 methods.
Table 3 — System accuracy results for glucose concentration < 100 mg/dL
Accuracy
Table 1 — System accuracy results for glucose concentration < 75 mg/dL
Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL
5 of 9 (55.6%) 9 of 9 (100%) 9 of 9 (100%)
Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL
160 of 186 (86.0%) 183 of 186 (98.4%) 186 of 186 (100%)
Table 4 — System accuracy results for glucose concentration ≥ 100 mg/dL
Within ± 5% Within ± 10% Within ± 15%
307 of 414 (74.2%) 411 of 414 (99.3%) 414 of 414 (100%)
Table 5 — System accuracy results for glucose concentrations between 37 mg/dL
and 478 mg/dL
Within ± 15 mg/dL or ±15%
600 of 600 (100%)
Technical Information
User Accuracy
User accuracy criteria require that 95% of all differences in glucose values (i.e., between
reference method and meter) should be within ±15 mg/dL for glucose values less than
75 mg/dL, and within ±15% for glucose values greater than or equal to 75 mg/dL.
The CONTOUR
®
NEXT LINK 2.4 blood glucose monitoring system was tested in a user
performance study by 218 people with diabetes using capillary blood samples and
3C
ONTOUR NEXT test strip lots. The results were compared to the YSI
®
glucose analyzer
laboratory reference method, traceable to the CDC hexokinase method.
8
The tables below
show how well the 2 methods compared.
85587269_CntrNextLINK_2_4_UG_EN_FpBp_v4.indd 57 11/18/16 9:03 AM
TECHNICAL
& CARE
56
WARNING
If you are experiencing any of these symptoms, test your blood sugar. If your
test result is under 50 mg/dL or above 250 mg/dL, contact your health care
professional immediately.
For additional information and a complete list of symptoms, contact your health
careprofessional.
®
Symptoms of High or Low Blood Sugar
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
(Hypoglycemia):
High blood sugar
(Hyperglycemia):
Ketones (Ketoacidosis):
• Shakiness
• Sweating
• Fast Heartbeat
• Blurred Vision
• Confusion
• Passing Out
• Irritability
• Seizure
• Extreme Hunger
• Dizziness
• Frequent Urination
• Excessive Thirst
• Blurred Vision
• Increased Fatigue
• Hunger
• Shortness of Breath
• Nausea or Vomiting
• Very Dry Mouth
85587269_CntrNextLINK_2_4_UG_EN_FpBp_v4.indd 56 11/18/16 9:03 AM
85587269_CntrNextLINK_2_4_UG_EN_FpBp_v5_UnMaskedPlaced.pdf:60