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What This Guide Helps With
Evaluate a reported probe, pipettor, or aspiration-type error by confirming the actual subsystem, sample preparation, cartridges, automation, and external causes first.
Step-by-Step Troubleshooting
1. Protect Specimens and Stop Unreliable Testing
Determine whether specimens are actively being processed. Do not continue testing through repeated liquid-handling or sample-processing errors if correct specimen processing cannot be assured.
Use an alternate validated testing pathway for urgent specimens.
Expected outcome: Specimen integrity and patient-result reliability are protected.
2. Confirm the Exact Reported Error
Record the exact message and determine which portion of the GeneXpert Infinity workflow generated it. The system uses assay cartridges and automation, so do not assume a conventional open pipettor or aspiration probe is present simply because staff describe the failure that way.
Expected outcome: The actual affected operation is identified before troubleshooting begins.
3. Verify the Sample and Cartridge
With laboratory personnel, confirm the correct specimen, preparation method, cartridge, and assay workflow were used. Inspect the cartridge externally for visible damage, leakage, contamination, or improper loading.
Do not open or modify closed cartridges.
Expected outcome: The sample and cartridge are appropriate and externally intact.
4. Check Sample Preparation Factors
Have laboratory staff confirm that required specimen preparation was performed according to their validated assay procedure. Clinical Engineering should not change clinical sample-processing technique.
Expected outcome: A preparation error is either identified by the laboratory or ruled out.
5. Inspect the Loading and Handling Path
Check accessible areas for improperly seated cartridges, foreign material, detached labels, spills, or other obstructions that could interfere with automation.
Clean only externally accessible surfaces using approved methods.
Expected outcome: The external loading and handling path is clear.
6. Determine Whether the Failure Is Cartridge-Specific
When laboratory procedure permits, compare behavior using another appropriate approved cartridge or specimen workflow.
Expected outcome: If the error does not recur with known-good material, the original consumable or preparation is isolated as the likely cause.
7. Determine Whether the Failure Is Module-Specific
Review whether the same error consistently occurs at one analyzer module or processing location.
Expected outcome: A repeatable module-specific pattern is identified or ruled out.
8. Verify System and Automation Readiness
Confirm the analyzer is fully initialized and that no broader automation, communication, motion, or system-readiness problem is present.
Expected outcome: The system is otherwise functioning normally or a broader equipment fault has been identified.
9. Check for Recent Changes
Ask whether the issue began after relocation, cleaning, maintenance, software changes, new consumable lots, or unusual environmental events.
Expected outcome: Any relevant external change is identified and evaluated before internal failure is assumed.
10. Perform Controlled Functional Verification
After correcting an external condition, have laboratory personnel perform an appropriate approved verification using nonpatient or otherwise suitable material according to laboratory procedure.
Expected outcome: The process completes without recurrence. If successful and laboratory acceptance requirements are met, troubleshooting can stop.
11. Escalate Repeated Processing Errors
If the error repeats despite correct sample preparation, approved cartridges, proper loading, clean accessible areas, and normal system readiness, stop external troubleshooting.
Expected outcome: An unreliable sample-processing pathway is removed from clinical service pending qualified evaluation.
If the Problem Persists
Common external cartridge, preparation, positioning, loading, and automation-path causes have been ruled out. The remaining problem may involve an analyzer module, cartridge-interface mechanism, internal motion or processing subsystem, sensor, or service-level software condition.
The affected GeneXpert Infinity system or module 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
Do not disassemble cartridge-processing mechanisms or perform unsupported internal adjustments. Complete applicable laboratory verification before return to service.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
When a sample-processing error repeats, preserve specimen identity and viability rather than repeatedly rerunning a limited patient sample.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported repeated sample-processing errors while cartridges were being run on the GeneXpert Infinity."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found one cartridge visibly damaged while the analyzer completed the same approved workflow normally with known-good material."
Resolution
What action was taken.
Example:
"Clinical Engineering removed the damaged cartridge from use, verified normal analyzer operation with laboratory-approved material, and returned the system for laboratory acceptance testing."
Helpful Details to Include (If Known)
- Exact error message
- Assay and cartridge involved
- Specimen type
- Cartridge condition
- Loading position
- Sample-preparation confirmation
- Whether the failure follows a cartridge or module
- Accessible contamination or obstruction
- Recent consumable or software changes
- Verification result
- Final equipment status
Final Thought
Translate the reported symptom into the actual GeneXpert workflow before assuming a specific internal mechanism has failed. Protect specimens, eliminate external causes, verify repeatability, and escalate persistent processing errors.
That is successful troubleshooting.