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What This Guide Helps With
Troubleshooting calibration, QC, Data Manager, host communication, or LIS result transmission issues using external and workflow checks first.
Step-by-Step Troubleshooting
Ensure Patient Safety First
Confirm the Atellica Solution is not actively processing urgent patient specimens affected by the reported issue.
If testing is delayed, misrouting, or producing questionable results, notify the lab to follow downtime or alternate analyzer workflow.
Expected outcome: Patient results are not released until calibration, QC, and communication status are verified.
Confirm the Exact Reported Failure
Ask laboratory staff what failed and when it started.
Identify whether the issue involves:
- Calibration failure
- QC failure
- Assay recovery issue
- QC not transmitting to Atellica Data Manager
- Patient results not transmitting to LIS
- Orders not downloading from LIS
- Data Manager communication error
- Host interface down
- Results stuck, pending, or rejected
Expected outcome: The issue is separated into analytical, middleware, or LIS communication failure before troubleshooting.
Check Analyzer Status and Active Alarms
Review the analyzer screen for system status, module alarms, reagent flags, calibration alerts, QC alerts, sample handling errors, or communication warnings.
Do not clear alarms without recording them if they may explain the failure.
Expected outcome: The analyzer provides a clear starting point for whether the issue is assay-related, module-related, or communication-related.
Verify the Correct Assay, Lot, and Calibration Requirements
Confirm the affected assay uses the correct reagent lot, calibrator lot, QC lot, and active calibration status.
Check whether a new reagent lot, calibrator lot, QC lot, or assay pack was recently loaded.
Expected outcome: Lot mismatch, expired material, missing calibration, or incorrect assay setup is ruled out before suspecting the analyzer.
Check Reagent, Calibrator, and QC Material Condition
Confirm reagents, calibrators, and QC material are not expired, improperly stored, contaminated, insufficient, or loaded in the wrong position.
Have lab staff verify preparation, reconstitution, mixing, thawing, and storage requirements according to lab procedure.
Expected outcome: Material handling problems are ruled out as the cause of calibration or QC failure.
Repeat Only Appropriate Calibration or QC Workflow
If lab policy allows, have authorized lab staff repeat the failed calibration or QC after verifying materials and setup.
Clinical Engineering should not override failed QC or release patient results.
Expected outcome: A one-time handling or setup issue may be corrected without unnecessary service escalation.
Check for Related Sample, Probe, Fluidics, or Reagent Handling Errors
Review whether the calibration or QC failure is accompanied by aspiration errors, clot detection, low liquid detection, reagent recognition faults, wash errors, or fluidics alarms.
These issues can cause poor recovery or invalid calibration even when the assay setup is correct.
Expected outcome: The calibration or QC problem is linked to a possible analyzer handling issue if related alarms are present.
Verify Atellica Data Manager Availability
Confirm the Atellica Data Manager workstation or server is powered on, logged in as required, and not frozen or displaying application errors.
Check whether other connected analyzers or modules are communicating normally.
Expected outcome: A local Data Manager application or workstation issue is separated from the analyzer itself.
Check Network Connections
Inspect Ethernet cables at the analyzer, Data Manager workstation, network switch, and wall jack if accessible.
Confirm link lights are present where visible.
Do not move network cables to undocumented ports unless directed by IT or the lab interface team.
Expected outcome: Loose, disconnected, or visibly damaged network connections are ruled out.
Confirm Whether the Failure Is Analyzer-to-Data Manager or Data Manager-to-LIS
Determine where the communication stops.
Check whether:
- Analyzer results reach Atellica Data Manager
- Data Manager can send results to LIS
- LIS orders reach Data Manager
- Data Manager can forward orders to the analyzer
- Only one assay, one module, or all results are affected
Expected outcome: The communication failure is narrowed to the analyzer, middleware, network, or LIS side.
Check for Interface Queue, Held Results, or Rejected Results
Review Data Manager status for held, pending, rejected, or untransmitted results.
Confirm whether results are being held due to QC rules, delta checks, missing demographics, invalid accession numbers, or LIS rejection.
Expected outcome: Results are not mistaken as “not transmitting” when they are actually being held by rules or rejected by LIS.
Check Recent Changes
Ask whether there were recent changes to:
- LIS configuration
- Data Manager rules
- Network ports or VLANs
- Analyzer configuration
- Assay setup
- Reagent or QC lots
- Interface engine settings
- Scheduled maintenance or software updates
Expected outcome: A recent change is identified as a likely cause before hardware repair is pursued.
Power Cycle Only When Safe and Approved
If the analyzer or Data Manager appears frozen or communication is down, coordinate with the lab before rebooting anything.
Confirm no active testing, critical samples, or pending transmissions will be interrupted.
Expected outcome: Controlled restart is performed only when safe and appropriate.
Test with a Known Workflow
After basic checks, have lab staff test a known valid workflow, such as a QC run, test order download, or result transmission according to site procedure.
Expected outcome: The team confirms whether the issue is resolved or still present after external checks.
If the Issue Resolves, Document and Return to Service
If calibration passes, QC is acceptable, Data Manager communication resumes, or LIS transmission is restored, confirm with lab staff before returning the analyzer to normal use.
Expected outcome: The device is operational and lab staff agree the issue is resolved.
If the Problem Persists
If calibration, QC, Data Manager, or LIS communication failure persists after material checks, lot verification, alarm review, network inspection, and workflow confirmation, common external causes have been ruled out.
The analyzer or related middleware/interface should be:
- Removed from routine use if patient testing or result integrity is affected
- Labeled Out of Service if the analyzer cannot safely produce or transmit valid results
- Escalated for Siemens service, bench evaluation, LIS/interface support, or IT network review as appropriate
Knowing when to stop is proper troubleshooting. Clinical Engineering should not bypass failed QC, force result release, or make undocumented interface changes.
Clinical Use Tip
Do not troubleshoot calibration, QC, or LIS failures while patient results are actively being released. If result accuracy or transmission is uncertain, have the lab use an approved alternate analyzer or downtime workflow until the issue is resolved. Move patient specimen testing to a backup device or approved downtime workflow first so therapy and result continuity are protected.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory reported the Atellica Solution was failing QC on chemistry assays and results were not transmitting through Atellica Data Manager to the LIS."
Cause
What was observed during troubleshooting.
Example:
"Found active QC holds in Data Manager and verified analyzer network link was present with no loose external connections; no hardware fault confirmed during initial troubleshooting."
Resolution
What action was taken.
Example:
"Verified reagent and QC lot information with lab staff, confirmed Data Manager queue status, coordinated LIS/interface review, and left analyzer restricted from affected testing pending successful QC and transmission verification."
Helpful Details to Include (If Known)
- Affected assay or module
- Calibration failure code or message
- QC level and lot number
- Reagent lot and expiration status
- Whether issue began after a lot change
- Analyzer alarms present
- Alarm behavior
- Accessories, reagents, calibrators, or QC materials swapped
- Power behavior
- Environmental factors
- Indicator lights
- Data Manager status
- LIS order download status
- Result transmission status
- Network cable/link light status
- Whether other analyzers are affected
- Any recent LIS, middleware, or network changes
- Final device status
Final Thought
Calibration, QC, middleware, and LIS issues should be approached carefully because they can affect patient result accuracy and reporting. Start with materials, lot setup, alarms, workflow, and network checks before escalating. Good documentation protects the patient, the lab, and the troubleshooting process.
That is successful troubleshooting.