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What This Guide Helps With
Troubleshoot reported calibration-related failures by checking system readiness, approved materials, environmental conditions, configuration, communication, and repeatability before escalation.
Step-by-Step Troubleshooting
1. Protect Patient Testing
Do not release results from an analyzer or affected module when required calibration or laboratory acceptance criteria have not been satisfied.
Coordinate alternate validated testing for urgent specimens.
Expected outcome: Patient testing does not depend on a system whose required calibration status is unresolved.
2. Confirm What Laboratory Staff Mean by Calibration Failure
Record the exact displayed message, test, verification process, or maintenance activity being described as a calibration failure. Determine whether the issue affects one module, multiple modules, or the entire system.
Do not assume the analyzer uses the same field-calibration process as another laboratory instrument.
Expected outcome: The actual failed operation and affected scope are clearly identified.
3. Verify System Initialization and Readiness
Confirm the GeneXpert Infinity has completed startup and is not showing unrelated hardware, automation, communication, or environmental warnings that could invalidate testing.
Expected outcome: The system is otherwise operational. If another primary fault is present, address or escalate that condition first.
4. Verify Approved Materials and Workflow
With laboratory personnel, confirm that any required cartridges, controls, calibration-related materials, or verification materials being used are correct for the intended procedure and have been stored and handled according to laboratory requirements.
Expected outcome: The correct approved materials and workflow are being used.
5. Inspect Consumables Externally
Inspect applicable materials for damage, contamination, compromised packaging, unreadable identification, or incorrect loading.
Do not modify or open closed assay cartridges for troubleshooting.
Expected outcome: Materials are externally intact and correctly loaded.
6. Check Environmental Conditions
Verify that the system has adequate ventilation and has not recently been moved, exposed to excessive temperature changes, or subjected to power interruptions or other unusual environmental conditions.
Expected outcome: No obvious environmental condition is interfering with reliable operation.
7. Check for a Module-Specific Pattern
Determine whether failures consistently occur in the same module or location while comparable operations succeed elsewhere. Use only laboratory-approved comparisons and do not move patient testing simply to force a diagnostic result.
Expected outcome: The failure is narrowed to a specific location or shown to affect the wider system.
8. Verify Software and Configuration Status
Confirm the correct validated workflow is selected and no recent software, configuration, assay-definition, or system change coincides with the problem.
Do not enter restricted service menus or alter validated settings without authorization.
Expected outcome: The system remains in its approved configuration.
9. Repeat Only When Procedurally Appropriate
If laboratory procedure permits repeating the failed verification using appropriate approved material, observe whether the failure repeats under the same conditions.
Avoid consuming multiple cartridges or controls through repeated attempts when the same failure continues.
Expected outcome: A successful repeat following correction of an external issue confirms recovery. A repeated failure supports escalation.
10. Complete Final Verification
If the problem is corrected, ensure the laboratory completes required acceptance, control, or quality processes before resuming patient testing.
Expected outcome: The analyzer or affected module meets laboratory requirements and is ready for clinical use. Troubleshooting can stop.
11. Escalate a Persistent Calibration-Related Failure
If approved materials, loading, system readiness, environment, configuration, and repeatability have been verified but the failure remains, stop external troubleshooting.
Expected outcome: The affected analyzer or module remains out of clinical use until qualified service evaluation is completed.
If the Problem Persists
Common external material, workflow, environmental, communication, and configuration causes have been ruled out. The remaining problem may involve an analyzer module, optical or thermal subsystem, control electronics, software, or another internal service-level 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
Required laboratory quality verification must be successfully completed before the affected system is returned to patient testing.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
A system that cannot satisfy required laboratory calibration or verification criteria should not be used to generate reportable patient results.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported that a required analyzer verification repeatedly failed on one GeneXpert Infinity module."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering confirmed correct materials and system configuration but found the failure remained isolated to the same module."
Resolution
What action was taken.
Example:
"Clinical Engineering removed the affected module from clinical use and escalated it for qualified service evaluation while maintaining testing on verified available capacity."
Helpful Details to Include (If Known)
- Exact calibration or verification message
- Affected module or system location
- Materials used
- Consumable condition
- Environmental conditions
- Whether the failure follows a module
- Recent power or software changes
- Configuration observed
- Repeat attempt result
- Laboratory acceptance result
- Final equipment status
Final Thought
Do not assume a calibration-related failure is an internal defect until materials, workflow, environment, and configuration are checked. Protect patient testing, verify recovery, and escalate persistent failures appropriately.
That is successful troubleshooting.