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ITC VerifyNow System Platelet Reactivity Test User Manual

Page 76

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Troubleshooting - 10

Page 72

14439.C 03/2013

VerifyNow System User Manual |

USA

No.

Issue Description

Resolution

21

Error - Low proximal

voltage
Test or EQC optical data

was outside expected

limits.
This event occurs during

a Failed EQC, and is

logged as Error 21 in the

event log.

Possible causes of this error include incomplete reagent reconstitution, a damaged EQC

device, faulty optical components, or excessive time between the blood draw into a syringe

and sample transfer to the sample tube or start of the test.
1) If running an EQC, verify the EQC device is not damaged.
2) If running a test, ensure that the sample was drawn correctly, that it was mixed

sufficiently but gently, and that the test was run within the time allotted for the test type (see

Chapter 6, Patient Testing).
3) Perform an EQC test (see Section 5.1). If the EQC is OK, attempt the test again.
4) If the EQC is not OK or the problem continues, call Technical Support.

22

Error - Low distal

voltage
Test or EQC optical data

was outside expected

limits

.

Possible causes of this error include incomplete reagent reconstitution, a damaged EQC

device, faulty optical components, or excessive time between the blood draw into a syringe

and sample transfer to the sample tube or start of the test.
1) If running an EQC, verify the device is not damaged.
2) If running a test, ensure that the sample was drawn correctly, that it was mixed

sufficiently but gently, and that the test was run within the time allotted for the test type (see

Chapter 6, Patient Testing).
3) Perform an EQC test (see Section 5.1). If the EQC is OK, attempt the test again.
4) If the EQC is not OK or the problem continues, call Technical Support.

23

Error DC agreement (IIb/

IIIa only)
There was significant

variation between the

internal controls.

A redundant test using the same reagents is run in one of the detection wells of the IIb/IIIa

test device as a control. This error occurs when the DC values vary significantly between

the two channels.
1) Perform an EQC test (see Section 5.1). If the EQC is OK, run WQC Level 2 (see Section

5.2.2).
2) If the EQC is not OK or the problem continues, call Technical Support.

24

Attention - Channel

slope agreement (IIb/IIIa)

OR

Clinical control units
There was significant

variation between the

internal controls or the

clinical control unit (CU) is

out-of-range.

In these cases, the event may be associated with the blood sample and the following

causes should be investigated:

The patient being tested is on an interfering substance. Refer to the package insert
for list of interfering substances.

An improper blood collection technique was used to draw the sample.

The discard tube was used to run the test.

The patient being tested has a low platelet count, a low hematocrit or an inherited
platelet disorder.

A WQC sample was run in Test mode rather than QC mode.

The Greiner sample tube is expired.

If none of the above can be determined to be the cause, run WQC Level 2 (see Section

5.2.2). If the problem continues, call Technical Support.

25

Error - Mean agreement

(IIb/IIIa Only)
There was significant

variation between the

internal controls.

For the IIb/IIIa test, a redundant test using the same reagents is run using one of the

detection wells of the IIb/IIIa test device as a control. This error occurs when the mean

values vary significantly between the two channels.
1) Perform an EQC test (see Section 5.1). If the EQC is OK, run WQC Level 2 (see Section

5.2.2).
2) If the EQC is not OK or the problem continues, call Technical Support.

26

Attention - Premature

sample tube
The sample tube was

inserted prior to the

prompt being displayed.

1) Discard the sample and the test device. Do not reuse.
2) Re-draw sample and perform another test with a new test device
NOTE: Make sure to wait for the sample tube prompt before inserting the tube into

the test device.

27

Attention - Test type not

supported
The type of test device

inserted is not supported

by this version of the

instrument’s software.

This event may occur after a software upgrade or following changes to the test device.
1) Check the printing on the test device pouch to ensure it is the type of test device desired.

If not, obtain the correct test device type, and repeat the test. If yes, perform an EQC test

(see Section 5.1). When running EQC, make sure to select the QC prompt and not the test

prompt.
2) If EQC test is OK, attempt the test again.
3) If the EQC is not OK or problem continues, call Technical Support.