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What This Guide Helps With
Troubleshooting QC failure, QC lockout, strip lot mismatch, control recovery issues, or reagent strip setup problems on the AE-4022.
Step-by-Step Troubleshooting
Ensure Patient Safety First
Confirm the AUTION ELEVEN AE-4022 is not being used to report active patient results while QC is failing or strip lot setup is questionable.
If testing is needed immediately, have laboratory staff use another validated analyzer or follow the approved downtime process.
Expected outcome: No patient results are released from an analyzer with unresolved QC or reagent strip concerns.
Confirm the Reported QC or Strip Lot Issue
Ask laboratory staff what specifically occurred.
Check whether the issue involves:
- QC failure
- QC lockout
- New strip lot not accepted
- Control results outside range
- Wrong strip type selected
- Expired strip lot
- Mismatch between bottle, analyzer setup, and QC material
- Failure after opening a new bottle of strips
- Repeated failure on one chemistry pad or multiple pads
Expected outcome: The issue is identified as a QC recovery, strip lot, setup, or workflow problem before assuming analyzer failure.
Verify the Correct Strip Type Is Being Used
Confirm staff are using ARKRAY AUTION Sticks 10EA intended for the AUTION ELEVEN AE-4022. ARKRAY lists AUTION Sticks 10EA as the test strips for the AE-4022, and the analyzer uses reflectance photometry to read urine chemistry strips.
Expected outcome: Incorrect, unsupported, or mixed strip types are ruled out.
If the wrong strip type was loaded or selected, stop testing, correct the setup per lab procedure, repeat QC, and do not release results from the incorrect setup.
Check Strip Bottle and Lot Information
Compare the physical strip bottle label to the lot information entered or selected on the analyzer.
Check:
- Lot number
- Expiration date
- Strip type
- Open bottle date, if used by facility policy
- Storage requirements
- Whether strips from different bottles were mixed
Expected outcome: The analyzer setup matches the actual reagent strip bottle in use.
If a lot mismatch is found, correct the lot setup according to facility procedure, run required QC, and stop if QC passes.
Check QC Material Information
Confirm the control material is correct for the AE-4022 urine strip method.
Verify:
- Control lot number
- Expiration date
- Open vial date
- Storage condition
- Expected ranges
- Control level being tested
- Whether the correct QC level was selected on the analyzer
Expected outcome: QC material problems are ruled out before suspecting analyzer performance.
Review QC Lockout or Operator Lockout Status
Check whether the analyzer is preventing testing due to QC requirements, expired QC, failed QC, or operator ID restrictions.
The AE-4022 supports QC lockout and operator ID lockout features, so a lockout may be a compliance setting rather than a hardware fault.
Expected outcome: The lockout reason is understood and not mistaken for analyzer failure.
If the analyzer is correctly locked out, have authorized laboratory personnel complete required QC or operator setup.
Repeat QC With Fresh Materials
Have laboratory staff repeat QC using:
- Fresh control material
- A properly stored strip bottle
- Correct strip lot selection
- Correct control level selection
- Clean sample application technique
Expected outcome: QC passes when fresh, correctly matched materials are used.
If QC passes, document the issue as reagent/control/setup related and return the analyzer to service per lab policy.
Check Strip Handling and Timing
Confirm strips are not being exposed to room air for extended periods before use.
Verify staff are applying control material evenly and placing the strip correctly. The AE-4022 allows continuous strip placement and automatically aligns strips, but poor strip handling can still affect QC recovery.
Expected outcome: Strip application, timing, and placement issues are ruled out.
Inspect the Strip Feed and Reading Area
With testing stopped, inspect the user-accessible strip path for:
- Dried control material
- Urine residue
- Dust or debris
- Misplaced strip
- Sticky strip movement
- Obstruction near the read area
Clean only according to approved operator-level cleaning procedures.
Expected outcome: Contamination or obstruction is not affecting strip positioning or optical reading.
Check Environmental Conditions
Confirm the analyzer, strips, and controls are being used in an appropriate lab environment.
Look for:
- Excessive heat or cold
- Direct sunlight
- High humidity
- Storage near sinks or vents
- Controls or strips left uncapped
- Recent relocation of the analyzer
Expected outcome: Environmental causes of abnormal QC recovery are ruled out.
Power Cycle Only When Safe
If the QC setup appears correct and the analyzer is idle, restart the analyzer.
Allow it to complete startup checks before repeating QC.
Expected outcome: Temporary software or workflow state issues clear without interrupting patient testing.
Verify Final Status
After corrective action, confirm:
- QC passes
- Correct strip lot is active
- QC lockout is cleared
- No patient results were released during failed QC
- Analyzer status is acceptable for use
Expected outcome: The analyzer is safe to return to service.
If the Problem Persists
If QC continues to fail after confirming strip type, lot setup, control material, storage, handling, cleaning, and environmental conditions, common external causes have been ruled out.
Remove the AUTION ELEVEN AE-4022 from service, label it Out of Service, and send it for repair or bench evaluation. Possible internal causes may include optical read issues, strip transport alignment problems, sensor problems, or software/configuration faults requiring authorized service support.
Knowing when to stop is proper troubleshooting. Do not keep repeating patient testing or QC attempts on an analyzer that cannot produce acceptable QC.
Clinical Use Tip
Do not troubleshoot QC failures around active patient testing. Move testing to another validated analyzer or approved downtime method first. QC failure means result reliability is not proven.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory reported the ARKRAY AUTION ELEVEN AE-4022 failed QC after a new AUTION Sticks 10EA strip bottle was placed into use."
Cause
What was observed during troubleshooting.
Example:
"Strip lot entered on the analyzer did not match the lot number on the active reagent strip bottle."
Resolution
What action was taken.
Example:
"Corrected strip lot setup with laboratory staff, repeated QC successfully, verified QC lockout cleared, and returned analyzer to service."
Helpful Details to Include (If Known)
- Outlet tested
- Power cycle performed
- Strip type verified
- Strip lot number checked
- Control lot and expiration checked
- QC level affected
- QC lockout status
- Error or lockout message shown
- Strip bottle storage condition
- Control storage condition
- Reading area inspected or cleaned
- Any unusual sounds, heat, smell, or visible contamination
- Final device status
Final Thought
QC and strip lot issues should be handled carefully because they directly affect result reliability. Start with the strip bottle, control material, setup, and operator workflow before suspecting analyzer failure. Clear documentation helps show that patient safety, QC compliance, and logical troubleshooting were followed.
That is successful troubleshooting.