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Asset Type
Viscoelastic Hemostasis Analyzer
Manufacturer
Model
What This Guide Helps With
Troubleshoots recurrent invalid or incomplete assays caused by specimen, cartridge, loading, environment, software, or analyzer performance problems.
Step-by-Step Troubleshooting
1. Protect Patient Care
Do not continue relying on an analyzer producing repeated invalid, error, or incomplete results.
Transfer clinically necessary testing to another verified analyzer or approved laboratory method.
Expected outcome: Patient testing continues through a reliable pathway.
2. Characterize the Failure Pattern
Record whether:
- The same assay repeatedly fails.
- Multiple assay types fail.
- One patient specimen fails.
- Multiple specimens fail.
- The issue occurs with one cartridge lot.
- The failure happens at the same stage each time.
Expected outcome: A repeatable pattern is established that can separate specimen, cartridge, and analyzer causes.
3. Record the Exact Analyzer Message
Capture the precise invalid, error, or incomplete-result message and the point in the test where it occurred.
Expected outcome: The reported condition is documented without guessing at an error code or cause.
4. Evaluate the Specimen
Check for obvious specimen concerns:
- Insufficient volume.
- Visible clotting.
- Bubbles.
- Leakage.
- Improper handling.
- Delayed or compromised specimen condition.
Coordinate specimen questions with laboratory personnel.
Expected outcome: An unsuitable specimen is replaced through the normal clinical workflow. If a suitable replacement specimen tests successfully, troubleshooting can stop.
5. Replace the Cartridge
Inspect the original cartridge and use an appropriate known-good replacement.
If practical, use another lot to eliminate a recurring lot-specific disposable issue.
Expected outcome: The assay completes normally with a known-good cartridge. If so, remove the suspect disposable from use and document the finding.
6. Inspect the Loading Area
Visually inspect accessible cartridge-loading surfaces for:
- Debris.
- Dried sample.
- Contamination.
- Foreign material.
- Signs of liquid intrusion.
- Visible damage.
Clean only externally accessible areas using approved practices.
Expected outcome: The loading area is clean, dry, and unobstructed.
7. Check Environmental Conditions
Verify stable placement and absence of excessive vibration, temperature extremes, spills, condensation, or other obvious environmental disturbance.
Expected outcome: The analyzer operates in a stable environment. Correct any external condition and repeat verification.
8. Verify Software Responsiveness and Power Stability
Confirm:
- Normal startup.
- Responsive touchscreen.
- No freezing.
- No unexpected restart.
- Secure power connection.
Perform a controlled normal restart if appropriate.
Expected outcome: The analyzer returns to a stable ready state.
9. Repeat Testing With Controlled Variables
Use a known-good cartridge and suitable verification material or specimen in accordance with laboratory policy.
Where possible, change one variable at a time so the cause can be isolated.
Expected outcome: The analyzer repeatedly produces a complete valid result. If so, troubleshooting can stop after required verification.
10. Escalate Recurrent Invalid Results
If multiple known-good cartridges and suitable samples continue producing invalid or incomplete results, remove the analyzer from service.
Expected outcome: The unreliable analyzer is prevented from being used for patient testing pending qualified evaluation.
If the Problem Persists
External causes involving specimen quality, cartridge condition, loading area contamination, environmental stability, software responsiveness, and power have been ruled out. Remaining categories include internal measurement, cartridge interface, processing, software, sensing, or another service-level problem.
The device should be:
- Removed from service.
- Labeled Out of Service.
- Sent for repair or bench evaluation.
- Evaluated using appropriate manufacturer documentation and approved test equipment.
- Repaired or configured only by qualified personnel.
Successful QC and applicable functional testing should be completed before return to clinical service.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
Repeated invalid results are themselves evidence of unreliable performance; do not keep consuming patient samples in an attempt to obtain one acceptable result.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported multiple incomplete TEG 6s assay results during routine testing."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found dried sample residue in the accessible cartridge-loading area that interfered with consistent cartridge seating."
Resolution
What action was taken.
Example:
"Cleaned the accessible loading area using approved practices, verified normal operation with appropriate known-good cartridges and successful repeat testing, and returned the analyzer to service."
Helpful Details to Include (If Known)
- Exact invalid or error message.
- Assay affected.
- Number of failed tests.
- Cartridge lot.
- Specimens affected.
- Sample condition.
- Known-good cartridge result.
- Loading-area condition.
- Environmental observations.
- Restart result.
- Final QC or functional verification.
- Exact invalid or error message.
- Assay affected.
- Number of failed tests.
- Cartridge lot.
- Specimens affected.
- Sample condition.
- Known-good cartridge result.
- Loading-area condition.
- Environmental observations.
- Restart result.
- Final QC or functional verification.
Final Thought
Repeated invalid results should be treated as a reliability problem, not normalized as random events. Rule out specimen and disposable causes, verify repeatable performance, and escalate when consistency cannot be restored.
That is successful troubleshooting.