Accumetrics VerifyNow User Manual page 97

No. Issue Description
22 Error - Low distal
voltage
Assay or EQC optical
data was outside
expected limits.
Error DC agreement
23
(IIb/IIIa only)
There was significant
variation between the
internal controls.
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.
25 Error - Mean
agreement (IIb/IIIa
Only)
There was significant
variation between the
internal controls.
VerifyNow System User Manual
Resolution
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 assay.
1) If running an EQC, verify the device is not damaged.
2) If running an assay, ensure that the sample was drawn correctly,
that it was mixed sufficiently but gently, and that the assay was run
within the time allotted for the assay type (see Chapter 6, Patient
Testing).
3) Perform an EQC test (see Section 5.1). If the EQC is OK, attempt
the assay again.
4) If the EQC is not OK or the problem continues, call Customer
Support.
A redundant assay using the same reagents is run in one of the
detection wells of the IIb/IIIa assay 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 Customer
Support.
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 assay.
•
The patient being tested has a low platelet count, a low
hematocrit or an inherited platelet disorder.
•
The assay device was exposed to excess humidity prior to
running.
•
A WQC sample was run in Assay 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 Customer
Support.
For the IIb/IIIa assay, a redundant assay using the same reagents is
run one of the detection wells of the IIb/IIIa assay 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 Customer
Support.
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