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Manufacturer
Model
What This Guide Helps With
Troubleshoot cartridge or reagent recognition, identification, inventory display, workflow selection, barcode, loading, and configuration problems.
Step-by-Step Troubleshooting
1. Protect Patient Testing and Specimen Integrity
Determine whether the recognition problem affects pending patient testing. Do not continue using a cartridge, reagent, or consumable that the system cannot reliably identify.
Coordinate alternate testing when clinically necessary.
Expected outcome: Unrecognized material is not used for patient testing until its status is resolved.
2. Confirm the Exact Recognition Problem
Determine whether the system fails to recognize one cartridge or consumable, shows incorrect inventory information, reports unavailable material, or displays information inconsistent with what laboratory staff loaded.
Record the exact message and the affected item.
Expected outcome: The complaint is clearly defined as a single-item issue, loading issue, identification issue, inventory display issue, or broader system problem.
3. Verify the Correct Cartridge or Consumable
With laboratory personnel, confirm the correct assay cartridge or other applicable consumable is being used for the intended validated test workflow.
Inspect packaging and identification information without interpreting expiration or acceptance outside laboratory policy.
Expected outcome: The correct material is being used for the intended assay and workflow.
4. Inspect Identification Features
Inspect accessible labels and barcodes for damage, smearing, wrinkles, moisture, contamination, or obstruction. Confirm the identification area is not covered by another label.
Expected outcome: Identification markings are intact and readable.
5. Verify Loading and Orientation
Confirm the cartridge or applicable material is loaded in the correct location and orientation according to the laboratory's validated process. Check for incomplete seating or obvious obstruction.
Expected outcome: The material is positioned correctly for system recognition.
6. Compare With a Known-Good Item
When laboratory policy permits, compare the affected item with another known-good cartridge or consumable from an approved lot or supply.
Do not transfer patient material or alter consumables solely for troubleshooting.
Expected outcome: If the known-good item is recognized normally, the problem is isolated to the original material rather than the analyzer.
7. Inspect Accessible Reader Areas
Inspect accessible barcode-reading or identification surfaces for contamination or obstruction. Clean only according to approved external cleaning practices.
Expected outcome: External identification surfaces are clean and unobstructed.
8. Verify Inventory and Workflow Information
Review the displayed inventory or assay information with laboratory staff. Confirm that the correct workflow, test selection, and user-accessible configuration are active and that no recent software or configuration change coincides with the issue.
Do not alter validated assay configuration or restricted settings.
Expected outcome: Displayed workflow and inventory information correspond to the intended laboratory process.
9. Verify System Communication
If inventory data are shared between workstation, automation components, or laboratory systems, confirm required communication connections are intact and that no broader network or software communication failure is present.
Expected outcome: Required communication pathways are available and no general communication fault explains the inventory discrepancy.
10. Perform Functional Verification
After correcting an external cause, verify that an appropriate approved cartridge or consumable is recognized and that the expected information appears correctly.
Expected outcome: Recognition and inventory display are accurate. If so, troubleshooting can stop after laboratory verification.
11. Escalate Persistent Recognition Errors
If correct material, labeling, loading, accessible scanner condition, workflow selection, and communication have been verified but recognition remains unreliable, stop external troubleshooting.
Expected outcome: Unreliable reagent or cartridge recognition is prevented from affecting clinical testing.
If the Problem Persists
Common external consumable, barcode, positioning, workflow, and communication causes have been ruled out. The remaining problem may involve an identification reader, software database, configuration, automation subsystem, or other internal service-level condition.
The GeneXpert Infinity should be:
- Removed from service if correct test-material identification cannot be assured
- Labeled Out of Service
- Sent for repair or appropriate service evaluation
- Evaluated using current manufacturer documentation and approved test equipment
- Repaired or configured only by qualified personnel
After repair or configuration correction, confirm accurate consumable recognition and complete any required laboratory verification before patient testing resumes.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
Do not bypass cartridge or reagent identification when doing so could create an assay-selection, traceability, or patient-result risk.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported that a cartridge was not being recognized by the GeneXpert Infinity."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the cartridge barcode label damaged while a known-good approved cartridge was recognized normally."
Resolution
What action was taken.
Example:
"Clinical Engineering removed the affected cartridge from the troubleshooting workflow, verified normal recognition with a known-good cartridge, and returned the system for laboratory verification."
Helpful Details to Include (If Known)
- Exact recognition or inventory message
- Cartridge or consumable involved
- Barcode condition
- Loading position and orientation
- Whether one item or multiple items are affected
- Known-good comparison result
- Reader-area condition
- Displayed inventory information
- Recent software or configuration changes
- Communication status
- Final system status
Final Thought
Correct assay-material identification is part of patient safety. Verify simple consumable and workflow causes first, escalate unresolved recognition problems appropriately, and document exactly what was found and verified.
That is successful troubleshooting.