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What This Guide Helps With
Troubleshoot repeated sample-quality or sample-volume errors by separating specimen preparation, cartridge, loading, and analyzer-related causes.
Step-by-Step Troubleshooting
1. Protect the Patient Specimen
Stop repeated attempts if continued testing could consume or compromise a limited patient specimen. Coordinate with laboratory staff regarding recollection, alternate testing, or use of another validated analyzer.
Expected outcome: The specimen is preserved as much as possible and patient testing remains supported.
2. Record the Exact Error
Capture the complete displayed error and identify the assay, cartridge, specimen, and module involved. Determine whether the message specifically identifies sample volume or whether staff are describing a suspected clot or bubble.
Expected outcome: The actual system-reported condition is documented accurately.
3. Have Laboratory Staff Verify Specimen Quality
Clinical laboratory personnel should inspect and assess specimen suitability according to their validated procedure, including any concerns involving inadequate volume, clots, bubbles, viscosity, or preparation.
Clinical Engineering should not make independent clinical acceptance decisions for specimens.
Expected outcome: Specimen-related causes are identified or reasonably ruled out by laboratory staff.
4. Verify Required Sample Preparation
Confirm with laboratory staff that the assay-specific specimen preparation process was followed and that no preparation step was missed or altered.
Expected outcome: The specimen was prepared according to the validated assay workflow.
5. Inspect the Cartridge
Inspect the cartridge externally for damage, leakage, contamination, deformation, or improper identification. Verify it is the correct cartridge for the selected assay.
Do not open or manipulate the internal contents of the cartridge.
Expected outcome: The cartridge is externally intact and appropriate for the test.
6. Verify Loading and Position
Confirm the cartridge is fully seated and correctly positioned in the intended loading workflow. Inspect accessible areas for debris or obstructions.
Expected outcome: Loading and positioning are correct.
7. Determine Whether the Error Follows the Specimen
Where laboratory procedures permit, compare results with another properly prepared specimen or approved verification material.
Expected outcome: If the error follows the original specimen, a sample-related cause becomes more likely.
8. Determine Whether the Error Follows a Cartridge or Module
Review whether repeated errors are associated with one cartridge lot, one individual cartridge, or one analyzer module.
Expected outcome: A repeatable consumable or module pattern is identified or ruled out.
9. Verify System Readiness
Confirm the system is fully initialized and free of broader module, automation, motion, temperature, or communication errors.
Expected outcome: No other equipment condition explains the repeated processing error.
10. Verify Successful Processing
After an external cause is corrected, have laboratory staff perform the appropriate approved verification.
Expected outcome: The sample-processing error does not recur and laboratory acceptance requirements are satisfied. Troubleshooting can stop.
11. Escalate Persistent Repeated Errors
If acceptable specimens, proper preparation, intact cartridges, correct loading, and system readiness have been confirmed but the error repeats, stop troubleshooting at the external level.
Expected outcome: The affected module or system is prevented from producing potentially unreliable results until serviced.
If the Problem Persists
Common specimen, cartridge, preparation, positioning, and loading causes have been ruled out. The remaining problem may involve an analyzer module, internal cartridge-interface mechanism, sensor, thermal or mechanical subsystem, or other service-level condition.
The affected GeneXpert Infinity module or system should be:
- Removed from service as appropriate
- Labeled Out of Service
- Sent for repair or qualified service evaluation
- Evaluated using current manufacturer documentation and approved test equipment
- Repaired or configured only by qualified personnel
Laboratory acceptance testing must be completed before returning the affected pathway to patient testing.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
Repeated runs can consume irreplaceable specimen volume; coordinate with the laboratory before attempting another test on a limited sample.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported repeated sample-volume errors when processing a patient specimen on the GeneXpert Infinity."
Cause
What was observed during troubleshooting.
Example:
"Laboratory review found the original specimen volume inadequate, while Clinical Engineering verified normal system operation with approved verification material."
Resolution
What action was taken.
Example:
"Clinical Engineering documented normal analyzer operation, laboratory staff redirected the inadequate specimen according to policy, and the analyzer remained available for clinical use."
Helpful Details to Include (If Known)
- Exact displayed error
- Assay and cartridge
- Specimen involved
- Laboratory assessment of specimen quality
- Sample-preparation confirmation
- Cartridge condition
- Affected module
- Whether the issue follows specimen, cartridge, or module
- Verification result
- Final system status
Final Thought
Repeated sample errors require cooperation between Clinical Engineering and the laboratory. Protect the specimen, separate sample and consumable causes from equipment causes, and escalate only after the external factors are properly evaluated.
That is successful troubleshooting.