Performance Characteristics; 10 Troubleshooting - Trividia Health TRUE METRIX GO Instructions For Use Manual

9

PERFORMANCE CHARACTERISTICS

PRECISION: Precision describes the variation between results. There are two types of precision
results measured - repeatability (using blood) and intermediate precision (using control solution).
Repeatability: N=100
Mean (mmol/L)
1.3 2.1
SD (mmol/L)
0.05 0.08
%CV
4.2 3.8
Intermediate Precision: N=100
Mean (mmol/L)
2.1 6.4
SD (mmol/L)
0.1 0.2
%CV
4.2 3.4
SYSTEM ACCURACY: Diabetes experts have suggested that glucose meters should agree within
+0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L
and within +15% of the medical laboratory values at glucose concentrations at or above
5.55 mmol/L. 6 The tables below show how often healthcare professionals (HCP) and users
achieve these goals using capillary fingertip, capillary forearm, and venous blood samples when
glucose results are not fluctuating. The laboratory reference instrument is the Yellow Springs
Instrument (YSI).
FOR HEALTHCARE PROFESSIONALS
99.5% of TRUE METRIX GO fingertip values performed by healthcare professionals (HCP) fell
within ±0.83 mmol/L of the YSI results at glucose levels <5.55 mmol/L and within ±15% at
glucose levels >5.55 mmol/L.
Fingertip Capillary Samples (HCP vs. YSI) for glucose concentrations <5.55 mmol/L
Within
+0.28 mmol/L
94 / 156 (60.3%)
Fingertip Samples (HCP vs. YSI) for glucose concentrations >5.55 mmol/L
Within + 5%
227 / 444 (51.1%)
Fingertip Samples for glucose concentrations between 1.1-33.3 mmol/L
Within +0.83 mmol/L or +15%
Parkes Error Grid: 100% of individual fingertip glucose measured values performed by
healthcare professionals fell within Zone A of the Parkes Error Grid (PEG).
98.2% of TRUE METRIX GO forearm values performed by healthcare professionals (HCP) fell
within ±0.83 mmol/L of the YSI results at glucose levels <5.55 mmol/L and within ±15% at
glucose levels >5.55 mmol/L.
Forearm Capillary Samples (HCP vs. YSI) for glucose concentrations <5.55 mmol/L
Within
+0.28 mmol/L
28 / 62 (45.2%)
Forearm Capillary Samples (HCP vs. YSI) for glucose concentrations >5.55 mmol/L
Within + 5%
74 / 156 (47.4%)
Forearm Samples for glucose concentrations between 1.1-33.3 mmol/L
Within +0.83 mmol/L or +15%
Parkes Error Grid: 99.1% of individual forearm glucose measured values performed by
healthcare professionals fell within Zone A and 0.9% in Zone B of the Parkes Error Grid (PEG).
Venous Blood
99.1% of TRUE METRIX GO venous values performed by healthcare professionals (HCP) fell within
±0.83 mmol/L of the YSI results at glucose levels <5.55 mmol/L and within ±15% at glucose
levels >5.55 mmol/L.
Venous Samples (HCP vs. YSI) for glucose concentrations <5.55 mmol/L
Within
+0.28 mmol/L
61 / 90 (67.8%)
Venous Samples (HCP vs. YSI) for glucose concentrations >5.55 mmol/L
Within + 5%
66 / 130 (50.8%)
Venous Samples for glucose concentrations between 1.1-33.3 mmol/L
Within +0.83 mmol/L or +15%
Parkes Error Grid: 100% of individual venous glucose measured values performed by
healthcare professionals fell within Zone A of the Parkes Error Grid (PEG).
FOR CONSUMERS
99% of TRUE METRIX GO fingertip values performed by users fell within ±0.83 mmol/L of the YSI
results at glucose levels <5.55 mmol/L and within ±15% at glucose levels >5.55 mmol/L.
Fingertip Samples (User vs. YSI) for glucose concentrations <5.55 mmol/L
Within
+0.28 mmol/L
13 / 17 (76.5%)
Fingertip Samples (User vs. YSI) for glucose concentrations >5.55 mmol/L
Within + 5%
46 / 83 (55.4%)
Fingertip Samples for glucose concentrations between 1.1-33.3 mmol/L
Within +0.83 mmol/L or +15%
Parkes Error Grid: 100% of individual fingertip glucose measured values performed by users
fell within Zone A of the Parkes Error Grid (PEG).
98.2% of TRUE METRIX GO forearm values performed by users fell within ±0.83 mmol/L of the
YSI results at glucose levels <5.55 mmol/L and within ±15% at glucose levels >5.55 mmol/L.
Forearm Samples (User vs. YSI) for glucose concentrations <5.55 mmol/L
Within
+0.28 mmol/L
13 / 31 (41.9%)
Forearm Samples (User vs. YSI) for glucose concentrations >5.55 mmol/L
Within + 5%
34 / 78 (43.6%)
Forearm Samples for glucose concentrations between 1.1-33.3 mmol/L
Within +0.83 mmol/L or +15%
Parkes Error Grid: 100% of individual forearm glucose measured values performed by users fell
within Zone A of the Parkes Error Grid (PEG).
USER PERFORMANCE EVALUATION: A study evaluating glucose values from fingertip
capillary blood samples obtained by 100 lay persons showed the following results:
100% within +0.83 mmol/L of the medical laboratory values at glucose concentrations
below 5.55 mmol/L and 98.8% within +15% of the medical laboratory values at glucose
concentrations at or above 5.55 mmol/L.
4.1 7.7 11.4 16.4
0.13 0.25 0.38 0.53
3.2 3.3 3.3 3.2
17.7
0.6
3.3
Within Within
+0.56 mmol/L +0.83 mmol/L
146 / 156 (93.6%) 155 / 156 (99.4%)
Within + 10% Within + 15%
383 / 444 (86.3%) 442 / 444 (99.5%)
597/600 (99.5%)
Within Within
+0.56 mmol/L +0.83 mmol/L
53 / 62 (85.5%) 60 / 62 (96.8%)
Within + 10% Within + 15%
132 / 156 (84.6%) 154 / 156 (98.7%)
214 / 218 (98.2%)
Within Within
+0.56 mmol/L +0.83 mmol/L
85 / 90 (94.4%) 90 / 90 (100%)
Within + 10% Within + 15%
122 / 130 (93.8%) 128 / 130 (98.5%)
218/220 (99.1%)
Within Within
+0.56 mmol/L +0.83 mmol/L
17 / 17 (100%) 17/17 (100%)
Within + 10% Within + 15%
73 / 83 (88.0%) 82/83 (98.8%)
99/100 (99.0%)
Within Within
+0.56 mmol/L +0.83 mmol/L
22 / 31 (71.0%) 31/31 (100%)
Within + 10% Within + 15%
64 / 78 (82.1%) 76 / 78 (97.4%)
107/109 (98.2%)
5
1. After inserting test strip, meter does not turn on.
Reason
Test strip inserted upside down
27.6
or backwards
0.75
2.7
Test strip not fully inserted
Test strip error
Meter is dead or there is not a
battery in the meter
Battery in the meter backwards Battery must be placed in meter with
Meter error
2. After applying sample, meter does not begin testing.
Reason
Sample drop too small
Sample applied after two
minute shut-off
Problem with test strip
Problem with meter
Use contact information at the bottom of the page for assistance.
Display
If error message still appears, any other error message appears, or
troubleshooting does not solve the problem, contact for assistance.
12
ELECTROMAGNETIC COMPATIBILITY
This meter meets the electromagnetic immunity requirements as per EN ISO 15197:2015.
It meets the electromagnetic emissions requirements as per EN 61326 series. Interference
from the meter to other electronically driven equipment is not anticipated. The
electromagnetic environment should be evaluated prior to operation of the device.
Do not use the meter in a very dry environment, especially one in which synthetic
materials are present. Do not use the meter close to sources of strong electromagnetic
radiation, as these may interfere with the proper operation.
10 TROUBLESHOOTING
Action
Remove test strip from meter. Re-
insert test strip correctly into the
meter.
Remove test strip from meter. Re-in-
sert test strip correctly into the meter.
Remove test strip from meter. Repeat
with new test strip.
Remove test strip from meter.
Replace battery in meter. Use new
test strip for testing.
positive ("+") side facing up.
Contact for assistance.
Action
Repeat test with new test strip and
larger sample drop.
Repeat test with new test strip. Apply
sample within 2 minutes of inserting
test strip into meter.
Repeat with new test strip. If testing
still has not begun, contact for
assistance.
Contact for assistance.
11 MESSAGES
Reason Action
Repeat with new test strip, using
capillary whole blood from the finger
Invalid or forearm or venous whole blood
Hematocrit collected only in a sodium heparin
blood collection tube.
If error persists, contact for assistance.
Temperature Move meter and test strips to area
Error between 5°C-40°C;
• wait 10 minutes for system to reach
Too Cold/ Too Hot room temperature before testing.
Sample Not Retest with new test strip and
Detected or
Sample Drop on Make sure Sample Tip of test strip
Top of Test Strip touched top of sample drop.
Used Test Strip, Repeat with new test strip.
Test Strip Outside
of Vial Too Long contact for assistance.
Meter Error Contact for assistance.
Retest with new test strip. If error
Test Strip Error or persists, contact for assistance.
Very High Blood If you have symptoms such as
Glucose Result fatigue, excess urination, thirst or
(higher than blurry vision, follow a Doctor or
33.3 mmol/L) Healthcare Professional's advice for
high blood glucose.
Test Strip
Unplug Micro USB cable. Repeat
Removed During
with new test strip. Make sure
Test or Micro USB
result is displayed
Cable
before removing test strip. If error
Connected while
persists, contact for assistance.
Testing
Meter Error Contact for assistance.
Low: About 50 tests can be done
before battery dies.
Low or Dead
Dead: Battery Symbol appears
Battery
before meter turns off.
Change the battery.
Do not use meter for testing.
Broken Display
Contact for assistance.
WARNING!!
Out of Range -
High Results
Retest with new test strip. If result
> 33.3 mmol/L
is still "Hi" (High) or "Lo" (Low)
contact a Doctor or Healthcare
Out of Range -
Professional immediately.
Low Results
< 1.1 mmol/L
SYSTEM SAFETY INFORMTION
larger sample.
If error persists,
WARNING!!