Afinion Error Codes

Cause

Insufficient sample volume:

• Empty capillary
• Air bubble in capillary
• Capillary incompletely filled

Action to Take

Repeat the test with a new sample and test cartridge.
Ensure that the capillary is completely filled with no air bubbles (see package insert for the Afinion Test in use).

Cause

Excess sample on the sampling device exterior

Action to Take

Repeat the test with a new sample and test cartridge. Ensure that only the tip of the capillary is in contact with the sample (see package insert for the Afinion Test in use).

Cause

Wrong sample material

Action to Take

Repeat the test with a new sample and test cartridge. Ensure that proper sample material is used (see package insert for the Afinion Test in use, section “Specimen collection and storage”).

Cause

Coagulated sample

Action to Take

Repeat the test with a new sample and test cartridge. The time from filling the capillary until analyzing the test cartridge should be as short as possible.

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Cause

Hemolysed blood sample or poor sample quality

Action to Take

Consult the Afinion Package Insert. Repeat the test with a new sample and test cartridge.

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Cause

Test cartridge or analyzer failure

Action to Take

Repeat the test with a new sample and test cartridge. If the problem persists, restart the analyzer and run controls.

Cause

Capillary cracked or damaged

Action to Take

Repeat the test with a new sample and test cartridge. Inspect the sampling device before use and handle with care.

Cause

Barcode label not readable (dirty or damaged)

Action to Take

Repeat the test with a new sample and test cartridge. If the problem persists, restart the analyzer and run controls.

Cause

No sampling device inserted
Sampling device belongs to another Afinion Test
Label on sampling device not readable (dirty or damaged)

Action to Take

Repeat the test with a new sample and test cartridge. Ensure that the correct sampling device is in place and that the sampling device label is clean

Cause

Test cartridge previously used

Action to Take

Repeat the test with a new sample and test cartridge.

Cause

Test cartridge has passed expiration date

Action to Take

Check expiry date on the foil pouch or kit container. Repeat the test using a new sample and a new test cartridge from another lot.

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Cause

The date in the analyzer is incorrectly set

Action to Take

Check the date in the analyzer to make sure it is set correctly. Repeat the test with a new sample and test cartridge.

Cause

Test cartridge temperature too low

Action to Take

Repeat the test with a new sample and a new test cartridge. Ensure that the operating temperature is within acceptable range (see package insert for the Afinion Test in use).

Cause

Test cartridge temperature too high

Action to Take

Repeat the test with a new sample and a new test cartridge. Ensure that the operating temperature is within acceptable range (see package insert for the Afinion Test in use).

Cause

Software upgrade is required to run this test.

Action to Take

Contact your local supplier for assistance.

Cause

Test cartridge or analyzer failure

Action to Take

Repeat the test with a new sample and test cartridge. If the problem persists, restart the analyzer and run controls.

Cause

Test cartridge or analyzer failure

Action to Take

Repeat the test with a new sample and test cartridge. If the problem persists, restart the analyzer and run controls.

Cause

Test cartridge or analyzer failure

Action to Take

Repeat the test with a new sample and test cartridge. If the problem persists, restart the analyzer and run controls

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Cause

Hemolysed blood sample or poor sample quality (Afinion HbA1c)

Action to Take

Consult the Afinion HbA1c Package Insert. Repeat the test with a new sample and test cartridge.

Cause

Hemolysed blood sample or poor sample quality (Afinion HbA1c)

Action to Take

Consult the Afinion HbA1c Package Insert. Repeat the test with a new sample and test cartridge.

Cause

Condensation detected on cartridge

Action to Take

Run a new test cartridge. Ensure that the cartridge is equilibrated to room temperature before the foil pouch is opened.

Cause

No registered supervisors in operator list

Action to Take

At least one supervisor is required in the operator list when the analyzer is configured to operator ID verified, (see page 14).

Cause

Cannot delete last supervisor

Action to Take

At least one supervisor is required in the operator list when the analyzer is configured to operator ID verified, (see page 14).

Cause

This assay type is not accessible to the operator

Action to Take

The operator logged in does not have access to run this assay type. Please contact your supervisor.

Cause

Operator ID is not found in operator list

Action to Take

When Operator ID with verification is enabled, operator ID entered is required to be present in the operator list, (see page 14). Please contact your supervisor.

Cause

The control lot has passed expiration date

Action to Take

Check the expiration date on the control lot package insert or kit box. Repeat the test using a sample from a new control lot.

Cause

Afinion Control Data is not recognised and is not stored in control lot database

Action to Take

Reenter the Afinion Control Data, (see page 16).

Cause

Control verification aborted

Action to Take

The Afinion Control Data entered was not recognised. The control test was aborted by the operator. Test result was not stored. Run new control test to reset QC lockout interval.

Cause

Required control test interval has expired. Patient testing is disabled for this assay

Action to Take

A passed control run must be performed according to configuration to unlock this assay for patient testing

Cause

Operator list or control lot database is full

Action to Take

The operator list can store 1000 operators and the control lot database can store 100 control lots. Delete an operator or control lot to enter a new item.