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What This Guide Helps With
Use when reagent identification, availability, position, quantity, or displayed inventory does not match the physically installed reagent.
Step-by-Step Troubleshooting
1. Protect Patient Testing
Do not release patient results from an assay when required reagent status is uncertain. Redirect affected testing if necessary.
Expected outcome: Patient testing proceeds only with verified reagent availability and identification.
2. Confirm the Exact Reagent Problem
Determine whether the reagent is completely unrecognized, assigned to the wrong position, shown with an incorrect quantity, or associated with an inventory warning.
Expected outcome: The problem is defined clearly enough to compare physical reagent status with the analyzer display.
3. Verify the Correct Reagent
Confirm the installed reagent is intended for the assay and analyzer workflow. Check labeling, lot identification, expiration information, and physical condition without altering manufacturer-controlled data.
Expected outcome: The reagent is appropriate, within the laboratory's acceptance criteria, and physically suitable for use.
4. Inspect Reagent Placement
Verify the reagent container is seated fully in the correct position and oriented properly. Look for packaging, caps, contamination, deformation, or an obstruction that could prevent correct placement or identification.
Expected outcome: The reagent is correctly installed and unobstructed.
5. Inspect Identification Features
Check accessible barcode or identification surfaces for damage, condensation, smearing, covering labels, or contamination. Clean only as permitted by approved procedures.
Expected outcome: Identification markings are readable and unobstructed.
6. Reseat or Compare With a Known-Good Reagent When Appropriate
Remove and reinstall the reagent according to the normal laboratory workflow, or compare with another approved reagent container if available. Avoid repeatedly introducing questionable reagent into patient testing.
Expected outcome: Correct recognition after reseating or substitution indicates the original placement or reagent container caused the issue. Troubleshooting can stop after inventory status is verified.
7. Verify Displayed Inventory and Position
Compare the physical reagent and location with the analyzer's normal inventory display. Confirm the system has updated recognition after the reagent is installed.
Expected outcome: The displayed reagent identity, position, and available status reasonably correspond with the physical reagent.
8. Perform Final Operational Verification
Confirm the reagent remains recognized through normal analyzer operation and that required QC or laboratory validation steps are satisfactory before releasing patient results.
Expected outcome: Reagent recognition is stable and the analyzer is ready for validated testing. Troubleshooting can stop.
If the Problem Persists
External reagent condition, placement, labeling, and normal inventory checks have been ruled out. The remaining issue may involve an identification reader, position sensor, reagent-management subsystem, internal controller, software/database condition, or service-level configuration problem.
Remove the analyzer from service for affected testing when reagent identity or availability cannot be assured. Label it Out of Service as appropriate and arrange qualified evaluation using Beckman Coulter documentation and approved test equipment. Internal repair or software/configuration changes should be performed only by authorized or qualified personnel.
Return the analyzer to service for the affected assay only after correct reagent recognition and required QC verification are completed.
Knowing when to stop external troubleshooting and escalate is proper troubleshooting.
Clinical Use Tip
Do not bypass reagent identification concerns simply because the reagent is physically present; correct reagent identity and status must be verified before patient results are trusted.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported that a newly loaded reagent was not recognized by the DxC 700 AU."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found contamination covering the reagent identification area and preventing reliable reading."
Resolution
What action was taken.
Example:
"The identification area was cleaned using the approved process, the reagent was reloaded, and correct recognition and inventory status were verified."
Helpful Details to Include (If Known)
- Reagent name and lot
- Reagent position
- Expiration status
- Physical container condition
- Barcode or identification condition
- Whether reseating changed the condition
- Known-good reagent comparison
- Displayed inventory status
- QC performed after correction
- Final reagent status
Final Thought
Verify the physical reagent, placement, and identification before suspecting internal reader or software problems. Protect patient testing until inventory status is trustworthy, escalate unresolved conditions appropriately, and document both correction and verification.
That is successful troubleshooting.