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What This Guide Helps With
Troubleshooting QC failures, abnormal urine strip recovery, or inconsistent chemistry results caused by external setup, strip, sample, or handling issues.
Step-by-Step Troubleshooting
Ensure Patient Safety First
Confirm the CLINITEK Advantus is not being used to report active patient results while QC or recovery is failing.
If patient testing is needed, have the lab use another validated analyzer or follow approved downtime/manual procedures.
Expected outcome: Patient results are not reported from an analyzer with unresolved QC or chemistry recovery concerns.
Verify the Reported QC Failure
Review which QC level failed and which chemistry pad or result was abnormal.
Note whether the issue affects one analyte, multiple pads, all strips, or only one QC level.
Expected outcome: The failure pattern is clear before parts or settings are suspected.
Confirm Correct Reagent Strip Type and Lot
Verify the urine reagent strips are the correct Siemens-compatible strip type for the analyzer configuration.
Check the strip bottle lot number, expiration date, and open-vial dating if used by the facility.
Expected outcome: The analyzer is being tested with the correct, in-date reagent strips.
If expired, wrong, or questionable strips are found, replace them and repeat QC. If QC passes, document and stop.
Inspect Strip Storage and Handling
Confirm the strip bottle was capped tightly, stored according to facility policy, and not exposed to moisture, heat, excessive light, or chemical vapors.
Check for discolored pads, swollen/desiccant issues, or strips that appear damaged.
Expected outcome: Strip degradation is ruled out as a cause of abnormal recovery.
If degraded strips are found, discard them per lab policy, open a new bottle, repeat QC, and stop if acceptable.
Verify QC Material Condition
Confirm the QC material is correct for urine chemistry testing, not expired, properly mixed, and stored according to the QC manufacturer’s instructions.
Check whether the same QC material has passed on another analyzer or with another strip bottle.
Expected outcome: The QC material itself is not the source of the failure.
Check QC Application Technique
Observe how QC is applied to the strip.
Confirm pads are adequately wetted without flooding, contamination, or carryover between levels.
Make sure excess QC is removed consistently according to lab procedure before the strip is loaded.
Expected outcome: Operator technique is consistent and not causing pad washout, under-wetting, or cross-contamination.
Inspect the Strip Loading Area
Check the strip table, feed area, and strip path for dried urine, QC residue, dust, strip fragments, or buildup.
Clean only according to approved facility and manufacturer cleaning practices.
Expected outcome: The strip is transported and read without residue interfering with pad positioning or color reading.
If cleaning resolves the QC issue, return the analyzer to service only after successful QC.
Confirm Strip Positioning and Feed Operation
Run a test and observe whether the strip advances normally, sits flat, and is positioned correctly for reading.
Look for skewing, delayed movement, jams, or inconsistent strip pickup.
Expected outcome: The strip moves through the analyzer predictably and aligns correctly during the read sequence.
Check Analyzer Settings
Verify the configured strip type, units, QC setup, and reporting settings match the facility’s current procedure.
Confirm no recent configuration change, software change, or strip lot transition occurred before the issue started.
Expected outcome: The analyzer settings match the reagent strips and lab workflow.
Repeat QC With Fresh Materials
Use a fresh strip bottle and properly prepared QC material.
Run QC again under controlled conditions.
Expected outcome: QC passes if the cause was strip degradation, QC material condition, or handling technique.
Compare Against Another Analyzer if Available
Run the same QC material and strip lot on another validated CLINITEK analyzer, if available.
Expected outcome: A passing comparison analyzer points back to the suspect unit; a failing comparison suggests strip, QC material, or lot issue.
Assess for Optical or Internal Read Concern
If correct strips, QC material, cleaning, handling, configuration, and comparison checks have been completed, suspect an internal optical/read system, transport, calibration-related, or analyzer hardware issue.
Expected outcome: Clinical Engineering stops external troubleshooting and escalates for bench evaluation or vendor service.
If the Problem Persists
If QC failure or abnormal chemistry recovery continues after strips, QC material, technique, cleaning, strip movement, settings, and comparison testing have been checked, common external causes have been ruled out.
The CLINITEK Advantus should be:
- Removed from service
- Labeled Out of Service
- Sent for repair, bench evaluation, or vendor service review
Knowing when to stop is proper troubleshooting. Continued testing on a urine analyzer with unresolved QC failure can create patient result risk.
Clinical Use Tip
Do not allow patient urine chemistry results to be reported from the analyzer until QC is acceptable. Move testing to another validated device or approved downtime method before troubleshooting continues.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Lab reported the CLINITEK Advantus failed urine chemistry QC with abnormal recovery on the control material."
Cause
What was observed during troubleshooting.
Example:
"Found expired/open-vial urine reagent strips in use, causing inconsistent chemistry pad response during QC testing."
Resolution
What action was taken.
Example:
"Replaced reagent strips with a new in-date bottle, verified strip setup, repeated QC successfully, and returned analyzer to service."
Helpful Details to Include (If Known)
- QC level failed
- Specific chemistry pad or analyte affected
- Strip lot number and expiration date
- QC material lot number and expiration date
- Whether a new strip bottle was tested
- Whether QC passed on another analyzer
- Strip feed or transport behavior
- Any visible residue in the strip path
- Recent configuration, strip lot, or QC lot changes
- Final device status
Final Thought
QC failure on a urine analyzer should be handled as a patient safety issue until proven otherwise. Start with the most common external causes: strips, QC material, handling, cleanliness, and configuration. If those checks do not restore acceptable QC, remove the analyzer from service and escalate appropriately. Clear CCR documentation protects the patient, the lab, and Clinical Engineering.
That is successful troubleshooting.