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What This Guide Helps With
Troubleshooting particle classification errors, excessive review flags, abnormal image review, or questionable urine microscopy categorization on the iQ200 Series.
Step-by-Step Troubleshooting
Ensure Patient Safety First
Confirm the iQ200 Series analyzer is not actively processing patient specimens before troubleshooting classification, imaging, or review flag concerns.
If patient testing is urgent, have laboratory staff use another validated analyzer or approved manual microscopy process.
Expected outcome: No questionable urine microscopy results are released while the issue is unresolved.
Stop Reporting Questionable Results
Ask laboratory staff whether any patient results were affected by abnormal particle classification or excessive review flags.
Confirm whether those specimens require manual review, repeat testing, or manual microscopy per lab policy.
Expected outcome: Results that may be misclassified are held or verified before release.
Confirm the Reported Classification Problem
Ask staff what they are seeing. Check whether the issue involves:
- Excessive review flags
- RBC, WBC, epithelial cell, bacteria, crystal, cast, yeast, or mucus misclassification
- Images appearing blurry or poorly focused
- High unclassified particle count
- Frequent manual review requirement
- Abnormal results that do not match expected specimen appearance
- Problem only with certain specimen types
Expected outcome: The complaint is narrowed to classification, image quality, specimen quality, or workflow.
Check Whether the Issue Is Isolated or Widespread
Determine whether the issue occurs on one sample, one shift, one operator, one rack, one specimen type, or all testing.
If only one specimen is affected, suspect specimen quality, contamination, inadequate mixing, or unusual sediment.
Expected outcome: A single-sample issue is separated from an analyzer-wide problem.
Verify Specimen Handling and Mixing
Confirm samples are fresh, properly labeled, adequately mixed, and processed within the laboratory’s allowed time window.
Poorly mixed urine can cause uneven particle distribution and unexpected classification or review flags.
Expected outcome: Specimen handling is not causing inconsistent particle results.
Inspect Sample Containers and Racks
Check that specimen containers are compatible, seated properly, filled to the required level, and free of exterior contamination.
Verify racks are clean, undamaged, and loaded correctly.
Expected outcome: Sample presentation to the analyzer is consistent and not interfering with aspiration or imaging.
Check for Visible Sample Issues
Ask lab staff whether affected samples are highly turbid, bloody, viscous, contaminated, or have heavy sediment.
These conditions can increase review flags and make automated particle classification less reliable.
Expected outcome: Abnormal specimen characteristics are recognized before assuming analyzer malfunction.
Review Recent QC Results
Confirm urine microscopy QC or applicable system QC has passed according to lab policy.
If QC is failing or trending abnormally, stop patient testing and address QC before continuing.
Expected outcome: The analyzer is not used for patient reporting unless QC status supports use.
Check for Recent Reagent, Control, or Consumable Changes
Ask whether controls, consumables, wash solutions, diluents, or related supplies were recently changed.
Confirm materials are correct, in date, properly stored, and installed as intended.
Expected outcome: Consumable or material issues are ruled out as the cause of abnormal classification behavior.
Inspect the Sample Aspiration Area Externally
Look for obvious leaks, dried urine residue, salt buildup, debris, or sample carryover around user-accessible sample handling areas.
Do not perform internal disassembly beyond approved operator-accessible cleaning.
Expected outcome: External contamination or carryover sources are identified and corrected if accessible.
Verify Routine Cleaning Was Completed
Ask staff when the last required cleaning or maintenance was performed.
Missed cleaning can contribute to carryover, debris, abnormal background, and increased review flags.
Expected outcome: Maintenance status is confirmed and overdue user-level cleaning is completed per facility procedure.
Review Image Quality With Laboratory Staff
Have qualified lab personnel review stored images from affected specimens.
Look for blurry images, excessive debris, particles at image edges, unusual background, or particles that appear inconsistent with the reported classification.
Expected outcome: The issue is confirmed as image/classification related rather than a normal review process.
Check for Persistent Background or Carryover Pattern
If similar particles appear across unrelated samples, suspect carryover, contamination, fluid path residue, or imaging background issue.
If the abnormal particles vary by sample, suspect specimen-related variation.
Expected outcome: A repeating analyzer pattern is distinguished from specimen-to-specimen variability.
Restart Only When Safe
If no samples are in process, perform a normal shutdown and restart according to local procedure.
Do not power cycle during active sample processing.
Expected outcome: Temporary software or processing state issues are cleared without risking active patient results.
Run QC or Known Acceptable Material After Restart
Have laboratory staff run appropriate QC or approved check material after restart and cleaning.
Confirm classification, imaging, and review flag behavior returns to expected operation.
Expected outcome: Analyzer performance is verified before returning to routine patient testing.
Check LIS or Middleware Interpretation Separately
If the analyzer classification appears correct but the LIS displays unexpected flags, review whether middleware rules, result mapping, reference ranges, or auto-verification rules changed.
Expected outcome: Analyzer classification issues are separated from downstream LIS or middleware flagging problems.
Return to Service Only If Results Are Reliable
If QC passes, image quality is acceptable, flags return to expected frequency, and laboratory staff confirm results are clinically reviewable, return the analyzer to service.
Expected outcome: The device is used only after result integrity has been confirmed.
If the Problem Persists
If abnormal particle classification, poor image quality, excessive review flags, or questionable microscopy results continue after specimen handling, QC, consumables, cleaning, restart, and LIS/middleware checks are ruled out, the issue may involve internal imaging, flow cell, fluidics, optics, camera, alignment, or software classification performance.
The device should be removed from service, labeled Out of Service, and sent for repair or bench evaluation by qualified service personnel or the vendor.
Knowing when to stop is proper troubleshooting. Continued patient testing with unreliable particle classification can create patient safety and diagnostic risk.
Clinical Use Tip
Do not troubleshoot classification or review flag problems while patient specimens are actively being processed. Move testing to another validated method first, and make sure questionable results are reviewed or repeated according to laboratory policy before release.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported excessive review flags and questionable particle classification on the Beckman Coulter iQ200 Series urine analyzer."
Cause
What was observed during troubleshooting.
Example:
"Found QC acceptable but multiple patient samples showed increased unclassified particles after missed user-level cleaning and visible residue near the sample handling area."
Resolution
What action was taken.
Example:
"Removed analyzer from active testing, had staff complete approved cleaning, restarted the analyzer, verified acceptable QC and image review performance, and returned unit to service."
Helpful Details to Include (If Known)
- Whether patient results were held, repeated, or manually reviewed
- Specific particles being misclassified
- Review flag frequency or pattern
- QC status before and after troubleshooting
- Whether issue affected one sample or all samples
- Specimen appearance: turbid, bloody, viscous, heavy sediment
- Cleaning or maintenance status
- Consumables or controls recently changed
- Image quality observations
- Any visible residue, leaks, or carryover signs
- LIS or middleware flagging behavior
- Final device status
Final Thought
Particle classification issues require careful separation of specimen quality, QC status, maintenance, image quality, and LIS rule behavior before assuming internal failure. Patient safety comes first, and any questionable result should be reviewed through the laboratory’s approved process. Clear CCR documentation helps show what was checked, what was found, and why the device was either returned to service or escalated.
That is successful troubleshooting.