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What This Guide Helps With
Calibration or iQM3 quality-control failures caused by cartridge condition, analyzer readiness, environmental issues, consumables, configuration, or service-level faults.
Step-by-Step Troubleshooting
1. Protect Patient Testing
Do not report patient results from an analyzer when required calibration or quality-control status is unacceptable or unresolved.
Redirect testing to another verified analyzer or laboratory pathway until the GEM Premier 7000 meets all required quality requirements.
Expected outcome: Patient results are generated only on equipment with acceptable quality status.
2. Confirm the Exact Quality Failure
Record the exact displayed calibration, iQM3, or quality message and identify which analyte or analyzer function is affected when that information is provided.
Determine whether the condition is isolated, intermittent, or persistent.
Expected outcome: The specific quality-control condition is documented without assuming its cause.
If the analyzer subsequently completes its required quality processes successfully and no fault recurs, verify readiness before stopping.
3. Verify GEM PAK Recognition and Condition
Confirm the installed GEM PAK is properly recognized and that no loading, leakage, damage, or cartridge-related messages are present.
Inspect externally for obvious physical abnormalities without disturbing internal analyzer components.
Expected outcome: The GEM PAK is properly installed, recognized, and free from obvious external defects.
If correction of a cartridge installation problem restores acceptable analyzer quality status, proceed to final verification.
4. Verify Analyzer Startup and Stable Power
Confirm the analyzer has completed startup normally and remains on stable AC power. Check the power cord, plug, and outlet for obvious problems.
Unexpected restarts or power interruptions can interfere with analyzer readiness and quality processes.
Expected outcome: The analyzer remains continuously powered and stable during its quality processes.
If stable power resolves the problem and required quality checks pass, troubleshooting can stop after verification.
5. Check Environmental Conditions
Confirm the analyzer is located in its normal approved clinical environment and is not exposed to obvious excessive heat, cold, moisture, airflow, contamination, vibration, or recent relocation that could affect operation.
Do not invent or apply environmental limits; use current Werfen documentation for specific requirements.
Expected outcome: No obvious environmental condition is present that could interfere with calibration or analytical stability.
If correcting the environment results in successful required quality checks, verify the analyzer before return to use.
6. Verify External Consumables and Accessories
Check any user-replaceable consumables or externally handled items associated with the reported quality process for proper installation, condition, and compatibility.
Do not substitute unapproved materials.
Expected outcome: Required external consumables are correct, intact, and properly installed.
If replacement of an externally defective consumable resolves the quality failure, complete all required verification.
7. Review Configuration and Analyzer Status
Confirm the analyzer is operating under the expected facility configuration and has not recently undergone an unintended setting or software change.
Do not enter restricted service menus or change calibration parameters in an attempt to force acceptable results.
Expected outcome: The analyzer is using the expected approved configuration without obvious unintended changes.
If an authorized configuration correction resolves the issue, complete required quality checks before return to clinical use.
8. Allow Required Quality Processes to Complete
Follow normal analyzer prompts and approved procedures and allow the system to complete its intended calibration and iQM3 processes.
Do not repeatedly override or bypass failed quality conditions.
Expected outcome: Required calibration and quality processes complete successfully and the analyzer reaches acceptable clinical readiness.
If all required quality indications are acceptable, troubleshooting can stop.
9. Escalate Persistent Quality Failure
If calibration or iQM3 failures persist after external checks, remove the analyzer from service.
Do not make undocumented internal adjustments, alter analytical calibration values, or bypass quality safeguards.
Expected outcome: A persistent analytical, cartridge, sensor, fluidic, electronic, or software condition is escalated for qualified evaluation.
If the Problem Persists
External cartridge, power, environmental, consumable, readiness, and configuration causes have been ruled out. Remaining possibilities include analytical system issues, cartridge-related internal conditions, sensors, fluidics, software, or other service-level problems.
The analyzer should be:
- Removed from service
- Labeled Out of Service
- Sent for repair or bench evaluation
- Evaluated using appropriate Werfen documentation and approved test equipment
- Repaired or configured only by qualified personnel
All required quality-control and return-to-service criteria must be satisfied before patient testing resumes.
Knowing when not to bypass a quality failure is proper troubleshooting.
Clinical Use Tip
An analyzer that has not met its required quality checks should never be used simply because a patient result appears clinically reasonable.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Clinical staff reported that the GEM Premier 7000 remained unavailable because its required quality process would not complete successfully."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the GEM PAK was not fully seated and the analyzer showed an associated cartridge condition."
Resolution
What action was taken.
Example:
"Correctly reseated the GEM PAK, allowed the analyzer to complete its normal quality processes, verified acceptable analyzer status, and returned the unit to service."
Helpful Details to Include (If Known)
- Exact calibration or iQM3 message
- Affected analyte or function if displayed
- GEM PAK status
- Analyzer startup status
- AC power condition
- Environmental observations
- Recent cartridge replacement
- Recent configuration or software changes
- Quality results after corrective action
- Final analyzer status
Final Thought
Quality failures require patient testing to be redirected until the analyzer is proven acceptable. Rule out cartridge, power, environment, consumables, and configuration issues before assuming internal failure, then escalate unresolved analytical problems with complete documentation.
That is successful troubleshooting.