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What This Guide Helps With
Evaluate a reported wash, waste, or fluidics-related fault while recognizing the cartridge-based GeneXpert workflow and avoiding unsupported internal fluid-path troubleshooting.
Step-by-Step Troubleshooting
1. Protect Active Testing
Determine whether cartridges or patient specimens are actively processing. If the system cannot process specimens reliably, coordinate alternate validated testing before disrupting the analyzer.
Expected outcome: Clinical testing continuity is maintained and active specimens are protected.
2. Confirm the Exact Fault
Record the exact displayed message and identify which system component, module, or workflow generated it. Do not assume a conventional external wash or bulk-fluid system exists because staff describe the problem as a “fluidics” fault.
Expected outcome: The reported problem is tied to the actual GeneXpert Infinity subsystem involved.
3. Inspect for Visible Leakage or Contamination
Without opening equipment, inspect accessible areas around loaded cartridges, handling locations, and the exterior of the analyzer for liquid, residue, damaged cartridges, or unusual odor.
If active leakage is present, stop use.
Expected outcome: No external leak or contamination is present. Visible leakage requires removal from service until the source is addressed.
4. Inspect the Cartridge Involved
If the fault occurred during a specific test, inspect the cartridge externally for cracks, leakage, deformation, contamination, or improper seating.
Use appropriate biological-safety precautions.
Expected outcome: The cartridge is externally intact. A leaking or damaged cartridge is removed from use according to laboratory procedure.
5. Check for External Obstructions
Inspect accessible loading and handling areas for debris, spilled material, labels, or other contamination that could interfere with cartridge handling.
Clean only with approved external procedures.
Expected outcome: Accessible areas are clean and unobstructed.
6. Determine Whether the Fault Follows a Cartridge
When laboratory procedure allows, compare operation using an appropriate known-good cartridge or verification workflow.
Expected outcome: If the fault does not recur, the original cartridge or test-specific condition is isolated as the likely cause.
7. Determine Whether the Fault Follows a Module
Review whether the same fault occurs repeatedly in one analyzer module or processing location.
Expected outcome: A module-specific pattern is identified or ruled out.
8. Verify General System Readiness
Check whether the system is fully initialized and whether other automation, module, temperature, power, or communication problems are present.
Expected outcome: The system is otherwise stable or a broader root condition has been identified.
9. Review Recent Cleaning or Spill Events
Ask whether the problem followed a cartridge leak, spill, cleaning activity, relocation, or other event that may have affected accessible system areas.
Do not introduce cleaning fluid into openings or internal assemblies.
Expected outcome: Any relevant external event is identified and addressed within approved cleaning limits.
10. Perform Functional Verification
After correcting an external cause, have laboratory personnel perform an appropriate approved verification.
Expected outcome: The fault does not recur and the laboratory accepts the system for testing. Troubleshooting can stop.
11. Escalate Persistent Fluidics-Related Faults
If cartridges, visible contamination, loading, module patterns, and general system status have been checked and the fault continues, stop external troubleshooting.
Expected outcome: The affected module or system is kept out of use until qualified service is completed.
If the Problem Persists
Common external cartridge, leakage, contamination, loading, and workflow causes have been ruled out. The remaining problem may involve the internal cartridge-processing interface, an analyzer module, mechanical components, sensors, or another service-level subsystem.
The affected GeneXpert Infinity system or module should be:
- Removed from service
- 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 attempt internal fluid-path cleaning or disassembly unless specifically authorized by manufacturer service documentation and training. Complete laboratory verification before return to patient testing.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
Treat any visible leakage from a diagnostic cartridge as both an equipment issue and a potential biological-contamination concern.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported a fluidics-related fault during processing on the GeneXpert Infinity."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found visible leakage from the cartridge involved while the analyzer exterior and accessible loading area remained undamaged."
Resolution
What action was taken.
Example:
"Clinical Engineering removed the leaking cartridge from the workflow, ensured the accessible area was handled according to approved contamination procedures, and verified normal operation with laboratory-approved material."
Helpful Details to Include (If Known)
- Exact displayed fault
- Cartridge and assay involved
- Presence of visible liquid or residue
- Cartridge condition
- Affected module
- Loading-area condition
- Recent spill or cleaning activity
- Whether the fault follows a cartridge or module
- Verification result
- Final equipment status
Final Thought
A reported fluidics fault should be tied to the actual GeneXpert cartridge-based workflow before internal failure is assumed. Check for damaged consumables and contamination first, then escalate persistent equipment faults safely.
That is successful troubleshooting.