DXH Troubleshooting FlowCharts WARNINGS AND PRECAUTIONS Read all product manuals and consult with Beckman Coulter-trained personnel before attempting to operate instrument. Beckman Coulter, INC., urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but it is not limited to, protective eyewear, gloves and suitable laboratory attire when operating or maintaining this or any other automated laboratory equipment. INTENTION FOR USE This document is not intended to replace the information in your Instrument Instructions for Use Manual (IFU). Information in the Instructions for Use Manual supersedes information in any other manual.
Daily Checks Background fails Still fails which parameter? WBC RBC HGB PLT DIFF NRBC RETIC Zap Apertures x3 Clear appropriate Apertures (WBC or RBC) through Dx Tools>Maintenance tab Clean Apertures, Perform HGB Blank Verification, Likely causes: - Microbubbles in sweepflow lines - Electronic noise, or -Diluent contamination Prime Sweepflow Rinse Mix Chamber Go to Dx Tools>VCSn tab, select Fluidic>Rinse mix Chamber>Start Perform in order, as needed: - Flush Flow Cell (no cleaner) Both, (Repeat 5x) - Flush Flow Cell with cleaner (5 mins) - Clear Flow Cell Aperture 3x Clean Apertures, Shutdown for 30 mins, Still fails Run a cassette load of samples. Repeat Daily Checks Still fails When was the diluent last changed? Prime diluent Still fails Coulter Customer Support Center Run cassette of samples, Shutdown for 30 mins, Diff, NRBC still fails Retic still fails Prime the Retic reagents (Dx tools>common Services tab) 2
QC 6C, Retic-X Which results are affected? CBC Parameters? (WBC, HGB, RBC, PLT, DIFF, NRBC, RETIC Parameters (%) Refer to QC 1 Refer to QC 2
QC 1 CBC parameters (WBC, RBC, HGB, MCV, PLT, MPV) Out of Range? R Flags? Voteouts? Parameter affected in same way for each level (ie all running H or L; or showing a bias in same direction, but within range)? Reagent/s changed recently? All levels of QC affected and results confirmed by running new vials of each Are the other levels showing a bias on the same side of the mean? New lot? Try another box of reagent t Resolved Resolved Coulter Customer Support Center to advise of findings and request replacement Trending noted? Sudden shift? (except for MCV which is expected to trend up over time) - Has calibration factor been changed recently? - Has PMI been done recently? - Has FSE visited for an issue and made adjustments (changed hardware etc)? Check calibration and adjust as needed Pass Pass Pass Possible dilution issue?hardware - Clean outside of BSV - Clear appropriate Apertures (in Dx Tools>Maintenance) - Perform repeatability Fail Repeat repeatability Fail - Perform Clean Apertures (in Dx Tools>Maintenance) - Perform repeatability Fail Repeat repeatability Fail New vial gives same result? New lot of QC? Lab can set own target (as per IFU) as long as CVs are within performance specifications. Contact Beckman Coulter Customer Support Center to advise of findings Coulter Customer Support Center 4
QC 2 Out of Range? R Flags? Voteouts? DIFF, NRBC, RETIC Reagent/s changed recently? All levels affected? Try new vial of same level. Issue persists? New lot? Try another box of reagent Issue persists R flags? Results out of range or no results? Vial related. System is okay to run. Coulter Customer Support Center to advise of findings and request replacement Issue resolved Perform Rinse Mix Chamber Go to Dx Tools>VCSn tab, select Fluidic>Rinse mix Chamber>Start When complete, Finish Diagnostics Results in range? Are patient samples giving R flags? System is okay to run (Refer to 6C QC IFU> Expected Results section) New kit lot of QC? Coulter Customer Support Center to advise of findings Perform in order, as needed: - Flush Flow Cell (no cleaner) Go to Dx Tools>Maintenance tab, select Flush Flow Cell.>Choose Both >Start (Repeat 5x) - Flush Flow Cell with Cleaner for 5 mins - Clear Flow Cell Aperture When complete, Finish Diagnostics Issue persists 5
SAMPLES Which results are affected? All Parameters? (WBC, HGB, RBC, PLT, DIFF, NRBC, RETIC) CBC parameters only? (WBC, HB, RBC, PLT) AMTC module parameters only? (DIFF, NRBC, RETIC) Refer to Samples 1 Refer to Samples 2 Refer to Samples 3
SAMPLES 1 All Parameters (WBC, HGB, RBC, PLT, DIFF% #, NRBC% #, RETIC% #) Check the Sample Aspiration Probe - has it been recently replaced? Check the aspiration line connected at the top of the probe. Check the probe is seated & screwed in correctly. Ver 1.3 (vember 2016) Possible blocked Sample Probe OR Sample Aspiration Syringe /Motor issue Is blood being pulled through to the Blood Sample Valve? Is Sample Aspiration Syringe moving up & down freely? Signs of leaking around aspiration syringe? Replace Sample Aspiration Probe Confirm which results are affected (cannot be all) and refer to appropriate flowchart for further troubleshooting Check thumbscrew at bottom of syringe is finger tight. - If already tight, syringe needs replacing. Coulter Customer Support Center - If loose, tighten and check results again Could be faulty syringe motor or syringe itself. Coulter Customer Support Center Beckman Coulter Technical Training 7
SAMPLES 2 CBC parameters only (WBC, HGB, RBC, PLT) Is the BSV moving during the analysis cycle? Go to Dx Tools>CBC tab, select Mechanical>Cycle BSV. Does the BSV respond? Coulter Customer Support Center Voteouts? (Partial or Total) Which parameter/s? ALL Plt only - Clean outside of BSV -Perform Cycle BSV Still no CBC results? Is Sample Aspiration Syringe moving up & down freely? WBC or RBC only HGB only WBC & HB RBC & PLT Check PLT histogram spike at 2fL? Possible causes: - microbubbles in sweepflow line, prime sweepflow - electronic noise, check cover in place - possible diluent contamination, change diluent Voteouts? (Partial or Total) result Perform Zap Apertures x3 Voteouts persist Is HGB lamp on when analyser is powered on? Perform Clean Apertures and HGB Blank Verification Problem persists Clear appropriate Apertures (RBC or WBC) (Dx tools >Maintenance tab) 3x Clean Apertures (Dx tools >Maintenance tab) - Check when DxH Lyse was last changed and replace if coincides with onset of the problem. Contact Beckman Coulter if issue not resolved. - Possible dilution issue (if both parameters are affected in the same direction (ie H or L) - Check BSV and appropriate pump for movement - Clean outside of BSV - Perform Cycle BSV from Dx Tools> Maintenance - Unresolved? Coulter Customer Support Center Could be faulty syringe motor or syringe itself. Check thumbscrew at bottom of aspiration syringe is finger tight and look for signs of leaking - If loose, tighten and check results again - If already tight, syringe needs replacing. - Coulter Support Center Voteouts persist Voteouts persist Coulter Support Ver 1.3 (vember 2016) Beckman Coulter Technical Training 8
SAMPLES 3 Check SAM. Is sample being dispensed to the chambers? Is the aspiration Syringe moving up & down freely? ALL no results, low events, R flags AMTC parameters only* (DIFF, NRBC, RETIC) Perform in order, as needed: DIFF only NRBC only RETIC only Pathway or Reagent specific *te if you observe %, but not absolute values, then the issue is with the 1 o parameter used for calculating the abs value (eg WBC for DIFF, RBC for RETIC). DV or Flow Cell Issue Cycle DV Go to Dx Tools>CBC tab, select Mechanical>Cycle DV. Does the DV respond? Coulter Customer Support Center Still no results - Flush Flow Cell (no cleaner) Go to Dx Tools>Maintenance tab, select Flush Flow Cell.>Choose Both >Start (repeat 5x) - Flush Flow Cell (with Cleaner) for 5 mins (repeat if needed) - Clear Flow Cell Aperture Check counts (% and # affected?), flags (R?) and error messages Perform Rinse Mix Chamber Go to Dx Tools>VCSn tab, select Fluidic>Rinse mix Chamber>Start. If not resolved, proceed to next step. Low events, Low event rate, Required parameters for generating dataplots missing, R flags High event rate, R flags Unlock DV Go to Dx Tools>CBC tab, select Mechanical>Unlock DV. Does the DV respond? Possible blockage inside DV or input line of Flowcell Perform in order, as needed: - Flush Flow Cell (no cleaner) Go to Dx Tools>Maintenance tab, select Flush - Flow Cell.>Choose Both >Start (repeat 5x) - Repeat Flush Flow Cell with Cleaner for 5 mins (repeat if needed) - Clear Flow Cell Aperture Check reagents. - Near end of open expiry? - Nearly empty? - Changed recently? Change relevant reagent pack Ver 1.3 (vember 2016) Coulter Customer Support Center Issue persists Beckman Coulter Technical Training 9