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What This Guide Helps With
Troubleshooting QC failure, strip lot setup errors, calibration strip issues, or abnormal urine strip recovery on the Roche Urisys 1100.
Step-by-Step Troubleshooting
Ensure Patient Safety First
Confirm the Urisys 1100 is not being used to report active patient results while QC is failing or strip lot setup is questionable.
If patient testing is needed, have staff use another validated analyzer or follow approved downtime/manual testing procedures.
Expected outcome: No patient results are released from an analyzer with unresolved QC or strip setup concerns.
Verify the Reported QC or Lot Setup Issue
Ask laboratory staff what specifically failed.
Check whether the issue involves:
- QC result outside acceptable range
- New strip lot not accepted
- Calibration strip setup failure
- Unexpected positive or negative chemistry recovery
- Repeated QC failure on one level
- Repeated QC failure across multiple pads
- Failure only after opening a new strip bottle or changing lot
Expected outcome: The issue is identified as QC recovery, lot setup, calibration, or operator workflow before troubleshooting continues.
Remove the Analyzer From Active Testing
Stop patient testing until QC and strip setup are verified.
Do not allow patient results to be reported if required QC has failed.
Expected outcome: The analyzer is treated as unavailable for patient testing until acceptable QC is restored.
Confirm the Correct Strip Type Is Being Used
Verify staff are using Roche-compatible urine test strips approved for the Urisys 1100 configuration.
Check the strip bottle label and confirm the lot matches what staff are attempting to run.
Expected outcome: Incorrect or incompatible strips are ruled out.
Check Strip Expiration and Open-Vial Dating
Inspect the urine strip bottle for expiration date, open date, and storage condition.
Confirm the cap was closed tightly and that strips were not exposed to moisture, heat, light, or contamination.
Expected outcome: Expired, degraded, or improperly stored strips are identified before suspecting analyzer failure.
If expired or questionable strips are found, replace with a valid lot, repeat setup/QC, and stop if QC passes.
Verify QC Material Condition
Confirm the QC material is the correct type for urine chemistry testing and has not expired.
Check open-vial stability, storage requirements, mixing requirements, and contamination risk.
Expected outcome: Failed recovery is not caused by expired, improperly stored, or mishandled QC material.
Confirm the Correct QC Level Was Used
Verify that the QC level run matches the expected level entered or selected in the workflow.
Ensure Level 1 and Level 2 controls were not reversed, mislabeled, or poured into the wrong container.
Expected outcome: A simple QC level mix-up is ruled out.
Check Operator Technique
Observe or review how the strip was dipped, blotted, and placed into the analyzer.
Confirm the strip pads are fully wetted, excess liquid is removed appropriately, and the strip is placed correctly without delay.
Expected outcome: QC failure is not caused by under-dipping, over-saturation, delayed placement, or poor strip handling.
Inspect the Strip Tray and Read Area
Power down the analyzer if needed and inspect the strip tray, insert area, and visible read surface for dried urine, QC residue, dust, strip fragments, or staining.
Clean only using facility-approved methods and Roche-approved cleaning guidance.
Expected outcome: Contamination or residue that could affect pad reading is removed.
If contamination is found and cleaning restores acceptable QC, document the cleaning and stop.
Confirm the Analyzer Completed Startup Normally
Power the Urisys 1100 off and back on according to normal user-level procedure.
Confirm it completes startup without error messages, abnormal sounds, or display issues.
Expected outcome: The analyzer is not failing basic startup checks before QC is repeated.
Check Calibration Strip or Setup Material
If the complaint involves strip lot setup or calibration, verify the correct calibration strip or setup material is available and in usable condition.
Inspect it for damage, contamination, bending, discoloration, or incorrect storage.
Expected outcome: The lot setup process is not failing due to a damaged or contaminated setup strip.
Verify Lot Setup Information
Confirm staff entered or loaded the correct lot information for the strip bottle being used.
Check for transposed numbers, incorrect lot selection, expired lot entry, or use of a previous bottle’s setup information.
Expected outcome: The analyzer setup matches the physical strip lot in use.
Repeat Lot Setup Using a Known-Good Strip Lot
If available, have the lab try a different valid strip bottle or known-good lot.
Do not mix strips from different bottles.
Expected outcome: If the issue follows one strip lot, the problem is likely reagent-strip related rather than analyzer related.
Repeat QC After Setup Is Verified
Once strips, QC material, technique, tray cleanliness, and lot setup are confirmed, repeat QC using fresh material.
Expected outcome: QC passes within the laboratory’s acceptable range.
If QC passes, return the analyzer to service per lab policy and document the corrected cause.
Look for Pattern Across Multiple Analytes
Review whether the failure affects one chemistry pad, several pads, or all pads.
Single-pad failures often point toward strip/QC material concerns, while broad abnormal recovery may suggest technique, contamination, calibration, or analyzer read issues.
Expected outcome: The failure pattern helps determine whether the problem is external or likely internal.
Do Not Adjust Internal Components
Do not disassemble the optics, internal reader assembly, board assemblies, or transport mechanism during frontline troubleshooting.
Expected outcome: Troubleshooting remains appropriate for Clinical Engineering field support and avoids unnecessary device damage.
If the Problem Persists
If the Urisys 1100 continues to fail QC or reject valid strip lot setup after strips, QC material, operator technique, tray cleanliness, calibration/setup material, and lot information have been verified, common external causes have been ruled out.
The device should be removed from service, labeled Out of Service, and sent for repair or bench evaluation. The likely issue may involve the internal optics, strip detection, timing, calibration recognition, or reader electronics.
Knowing when to stop is proper troubleshooting. A urine analyzer that cannot pass QC should not be used for patient result reporting.
Clinical Use Tip
Do not troubleshoot QC or strip lot setup problems while the analyzer is being used for active patient testing. Move testing to another validated analyzer or approved downtime process first. QC failure means result reliability is not confirmed.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported the Roche Urisys 1100 failed urine chemistry QC after setting up a new reagent strip lot."
Cause
What was observed during troubleshooting.
Example:
"Found expired open-vial urine strips in use and confirmed the analyzer passed QC after setup with a valid strip lot."
Resolution
What action was taken.
Example:
"Removed expired strips from use, verified correct lot setup, repeated QC successfully, and returned the Urisys 1100 to service."
Helpful Details to Include (If Known)
- Analyzer removed from active testing
- Strip lot number checked
- Strip expiration and open date verified
- QC material expiration checked
- QC level confirmed
- Operator technique reviewed
- Strip tray inspected and cleaned
- Calibration/setup strip condition checked
- Error message or failed analytes documented
- Whether issue followed one lot or occurred across multiple lots
- Final QC result
- Final device status
Final Thought
QC failures on the Urisys 1100 should be approached logically: protect patient results first, verify strips and QC material, confirm setup information, inspect for contamination, and only then suspect internal failure. Clear CCR documentation helps show that the analyzer was evaluated safely and that unreliable results were not released.
That is successful troubleshooting.