Troubleshooting GeneXpert
Contents
1. Confidential La Cepheid QC 5 P Genes pert Dx System a s User Data Management Reports Setup View Results About User lt None gt Ai gt p Create Test Check Status Stop Test View Results Define Assays Define Graphs Maintenance 12753550 7 ar Sens Troubleshoot Primary Curve Sample ID oa Description Detail I Postrun Error 5006 2iC 1 probe check failed Probe check 1279395 0 analysis error value of 152 3 for reading number 1 was above the 2 Postrun Error 5006 2iC 1 probe check failed Probe check Assay pert MTB RIF Assa m 1 analysis error value of 152 0 for reading number 3 was above the G4 Version 5 Reagent Lot ID 11112 oe Test Type Specimen 3 Sample Type Other Other Sample Type y Views A Result View Notes 2 Primary Curve lt No Data Available gt Start Time 03 07 13 20 40 17 End Time 03 07 13 21 03 16 Status Aborted User sultuane Save Changes Export l Report Select Graphs View Test 4 Cepheid Confidential P EF ceph eid Troubleshooting section in Operator Manual Chapter 9 13 in current Operator Manual Error code Error message Possible causes Solution 5007 X probe check failed Probe check One or more of the following might Check the following value of n for r2. Incorrect sample volume Improper fluid transfer bubbles Incorrect storage of cartridges Probe integrity issues detected PGRB N127 lt No Data Available gt Start Time 28 02112 17 56 49 it ne _29 02121819 42 _ _ So Solution s Make sure the sample is totally liquefied before transferring to the cartridges gt If after 15 minutes of incubation with Sample Reagent sample is still too viscous do not load it into the cartridge Wait up to 10 more minutes Add from 2 to 4 mL of the preparation in the cartridges Avoid making bubbles Store the kits between 2 to 28 C A 16 Cepheid Confidential fA Cepheid Error Messages Abnormal Pressure detected 2008 System A t Data Minigame Reports Setup View Resutis Aboa User cephetd gt ee ii Problem sta tee ee iia iit I eSSUre reading exceeds the maximum ia S Mews Sa Evers aa 2008 Sampie ID wane mit of 120 0 PSI 351734 Origin wae SS i filer of cartridge is clogged due to too viscous sample or particles aire z Pressure sensor failed Swt Teme 1740220111 Solution s Make sure the sample is totally liquefied before transferring to the cartridges gt if after 15 minutes of incubation with Sample Reagent sample is still too viscous do not load it into the cartridge Wait up to 10 more minutes Make sure sample does not contain any solid particles Use anew cartridge and add only Sample Reage
3. power switch and computenrGenespert cable connections aap Run a test GeneXpert switched on before Computer i YES gt Modules available in software gt Check Status y Check Ethernet cable NS Loose or damaged 2 IP address setting lost 1 Right Ethernet port selected On desktop YES 3 Problem with LAN Port v Computer or GX IP address needs to be re E configured Contact Technical support 4 Problem with Gateway Replug or Replace l board or Modules Ethernet cable Test the Computer LAN port with a Ay printer to see if it works or not Module or Motherboard needs to R be replaced un a test Contact Technical support PA 10 Cepheid Confidential fZ Cepheid Contact Technical support emperature issues Error codes 1001 1002 2014 4009 etc Causes A heater component in a module is malfunctioning Ambient temperature is not within acceptable range Fan failure broken or filter is dirty Solutions Does this error affect only one module Always the same Check the internal temperature of the modules in the Maintenance menu Check room temperature must be 15 to 30 C Check the fan functionality exhaust at rear of the instrument Check the filters are clean Check clearance around the system must be 10 15 cm on all sides Freaoneia 11 Cepheid Confidential Stuck Cartridge A cartridge is stuck inside a GeneXpert modul
4. O RESULT Lo foriga Power failure during test ee Stop Test function was used a coo 3 accidentally or deliberately Computer freeze or crash during test Sample ID A A lt No Data Available gt Start Time 15 04 11 08 49 30 End Time 15 04 11 08 49 41 Status Aborted Solution Secure the power supply Use Stop Test only when its necessary Do not open other applications on the computer during tests 15 Cepheid Confidential Cepheid Error Messages Probe check failed 5006 5007 User Data Management Reports Setup View Results lt a HENEN Check Status View Results Define Graphs Mainte Moaie Name n Problem Probe Check control failed and test was stopped before amplification 18 19 19 nalysis Error 5007 QC 1 probe check failed Probe check value of 25 9 for eading number 2 was below the minimum of 32 0 Assay Xpert MTB RIF Assay 4 Z 4 Ay z a E i 4 G gt fE V S EREPEPEPEReeerereeeeeees ese rer eee rere rere rere ee eee ee ee tree ee ee ee ee ee ee ee eee eee eee eee eee eee eee ee eee eee eee e Eee e eee ee ee ee eT eee eee eee eee eee eee eee ee eee eee eee eee eee Version 5 AA ti zA TA A SE Reagent LotID 04202 fRes Z g Test Type Specimen OA ip Y A oa i Incorrect processing of sample viscosity I Other Sample Type OO
5. ROR result Click on Errors to know more about the specific issue Most freauenii issues linked to sampling are detailed in the next slides They should be addressed by operators following the advices contained in this document All other issues should be reported to Cepheid technical support group To easily reduce an unexpectedly high Error rate it is essential that all operators identify errors linked to C Cepheid Results with Errors INVALID Problem SPC Internal Control failed Al Test and Analyte Result Detail Errors Assay Name pert MTB RIF Wersion 1 Test Result INVALID Analyte Ct EndPt Analyte Result Mame ass T ir MAD Origin Ore a0 T ral PCR was inhibited due to inhibitors pus food particles RIKI RIS SIS Fluorescence Solution Before mixing with Cepheid sample reagent SR for decontamination check that Sample does not contain food particles pus Collect a new sample when necessary Fr ceoheic Results with Errors NO RESULT GeneXpert Dx System User DataManagement Reports Setup ViewResults About p Problem 1 a Hag a tal Che sil dete View Results efine cae efine Graphs m ce Test could not be terminated and ree aie Insufficient data were collected _ Primary Curve me pert Mi bD rK Test Result Result N
6. Troubleshootin Cepheid HBDC training 2013 A better way Troubleshooting Approach 1 In case of problem look for an error message on the screen pop up windows message box at the bottom of the screen or in the Error tab in the menu View Results 2 Look for the error code in the GeneXpert user manual and follow the recommended corrective actions oe lf the problem remains contact your local service provider if applicable or Cepheid assistance Technical hotline Europe based 33 5 63 82 53 19 support cepheideurope com Instrument errors Technical hotline U S A based 888 838 3222 Option 2 techsupport cepheid com Instrument errors 4 Continue to use other modules in the meantime if possible and exclude faulty module s from tests see slides 8 amp 9 2 Cepheid Confidential I Cepheid GeneX pert Dx System User Data Management Reports Setup Se Advanced Setup About a F Cj Check Status User support now PN Create Test Stop Test View Results Define Assays Define Graphs Maintenance Modules Tests Since Launch Module Sample Remaining Sample Mod Error Start Naina Assay ID Progress Status Test Time ID Na User Result Assay Status Status Date Messages Launched Genexpert Dx System at 120313 1530 32 Version 4 3 Modules not detected Check power switch and computen Genexpert cable connections p 3 Cepheid
7. c nE Ls Ey ma Tis MT aea Aai he F ree ti Cert p Jaon 3 qi Vn eee SAY H Era HENNI Piss PEEPI NEMS Se Fae a WT he Oe On the new windows that opens select Date range All Modules Currently Connected Modules Show Errors only Click on Preview PDF Save the file and send it to Cepheid Tech Support support cepheideurope com 6 Cepheid Confidential Cepheid TT How to obtain System Log Report System Log Report Select From MIDDINY To MDD Y Modules lt Currently Connected Modules All Logged Modules Select Module Name Module Serial Number saam Deselectan Selecttaotugtnea Desetecttigtagrted Show All Entries A Generate Report File Preview PDF So 7 Cepheid Confidential GeneXpert PC Selection Criteria Date Range Modules Show User Module Name B1 10 11 12 Description Termination error Termination error Termination error Termination error Termination error Termination error Termination error Termination error Termination error Termination error Termination error Termination error System Log Report All Currently Connected Modules Module B1 B2 B3 B4 Errors Only Byanyima Patrick Instrument S N Module S N 803498 631667 Detail Error 2127 Module communi
8. cation loss was 15 08 13 14 25 55 detected Error 2127 Module communication loss was 15 08 13 19 14 54 detected Error 2127 Module communication loss was 16 08 13 10 58 18 detected Error 2127 Module communication loss was 27 08 13 10 02 07 detected Error 2037 The cartridge integrity test failed 28 08 13 17 56 56 at valve position 0 The pressure change of 1 8 PSI did not exceed the requirement of 4 0 PSI The pressure increased from 2 1 PSI to 3 9 PSI during the test Error 2037 The cartridge integrity test failed 28 08 13 18 04 18 at valve position 0 The pressure change of 1 4 PSI did not exceed the requirement of 4 0 PSI The pressure increased from 2 1 PSI to 3 5 PSI during the test Error 2127 Module communication loss was 12 09 13 14 03 45 detected Error 2127 Module communication loss was 12 09 13 14 03 57 detected Error 2008 Syringe pressure reading of 25 09 13 11 56 48 120 2 PSI exceeds the protocol limit of 120 0 PSI Error 2127 Module communication loss was 26 09 13 20 12 47 detected Error 2127 Module communication loss was 22 10 13 12 09 59 detected Error 2127 Module communication loss was 06 11 13 20 13 22 GeneXpert Dx System Version 4 4a 02 12 13 11 30 24 Version 44a 44a 44a 44a 44a 44a 44a 44a 44a 44a 44a 44a Page 1 of 4 Z Cepheid E 2G eneXpert Dx System User Data Management Reports Setup About a User Administration Mee ype Lom
9. e Causes Module mechanical malfunction during the test Electrical failure Solutions 1 try to remove the cartridge from the software In the GeneXpert Dx window click Maintenance button On the Maintenance menu click Open Module Door Select the module Click Open Door to open the module door lf the door does not open restart the system and repeat the above steps 2 Manual removal of the cartridge lf above steps did not solve the issue contact Cepheid in order to be guided on how to remove module manually detailed procedure and online support will be provided A 12 Cepheid Confidential Z Cepheid 2 Genex pert Dx System f User ee I Setup View Results About Create Test Check Status Stop Test Module Name A2 Views Patient ID 7 Result View Primary Curve Sample ID Assay Xpert MTB RIF Ass G4 Version 5 Test Type Specimen Sample Type Other Other Sample Type Notes HPGRB CHIR No 226 Primary Curve Start Time 17 04 12 23 11 17 End Time 17 04 12 23 17 48 Status Aborted sample preparation 13 Cepheid Confidential A User ar Ca E EN View Results Define Assays Define Graphs Maintenance Test Result Detail History Assay Name Xpert MTB RIF Assay G4 7 Version 5 Test Result ERROR or In Vitro Diagnostic Use Only Cause Many different causes can lead to an ER
10. eading number m have caused the error Reagents are added to the cartridge was below the minimum of p An incorrect amount of reagent correctly x is the analyte name n m and p are was inserted into the cartridge Cartridges were stored correctly a 2 ie reagent is bad Rerun the test using fresh cartridges values can vary A f Fluid transfer failed If the error recurs call Cepheid The sample was processed Technical Support incorrectly in the cartridge 5008 X probe check failed Probe check One or more of the following might Check the following delta value n between reading have caused the error Reagents are added to the cartridge number m and reading number p Anincorrect amount of reagent correctly was below the minimum of q was inserted into the cartridge Cartridges were stored correctly x is the analyte name n m and pare Thereagentis bad values that the software displays The i values can vary Fluid transfer failed If the error recurs call Cepheid Technical Support Rerun the test using fresh cartridges 5 Cepheid Confidential Perhe Jow to obtain System Log Report Switch ON the GeneXpert Open the GeneXpert Software Click on Report then select System Log lt GeneXerie Dxs o Create Test Tn Lo j Test View Results Define Assays Define Graphs Maintenance Assay st TeenRepor z e E N I T O R TE TSA i a r a a S since Laun
11. iga ane II em Configuration aad a etea x M s bisane 2 View Results Define means hii Sample l Remaining Sample Mod ID Progress Status Test Time ID Click on Setup then System Pa system Configuration System Name Genexpert PE Date Format DDMM YY T Time Format 24 Hour HH mmss T configuration General _ Use Patient ID C Scan Patient ID Barcode Scan Sample ID Barcode Scan Cartridge Barcode Require Start Test Login o Never Always _ Start Test Login Timeout In Minutes 30 Click on the button Select Modules port At End of Test 4 Select Modules F Print r Assay Statisti Exclude Modules From Th on cancer 8 Cepheid Confidential Cepheid How to Exclude Module s from Tests Exclude Modules From Test X Select All SelectAll Deselect All Select Highlighted Select Highlighted Deselect Highlighted Deselect Highlighted 3 checking ihe box ers checking the box O U M TEHE TT A3 A4 LIL 4 Click on OK Excluded module s will not be usable anymore OK Cancel Once the situation is back to normal the module s must be removed from this list Freaoneia 9 Cepheid Confidential Modules not detected Messages Launched Genes pene Dx System at OBA ONS 17 55 26 Version 4 44 Modules not detected Check
12. nt if problem persists it s likely a module problem contact Cepheid EO Cepheid Error Messages Module communication loss was detected 2127 GeneXpert Dx System User Data Management Reports tto eraran ns 0 Problem Y N I gt i w manica T Check Status View Results Co unication IS lost between odules and software a i w i Origin Ethernet connection between PC and GX is bad Power supply issue main power or UPS fluctuations Bad connection points between Gateway Board wee and modules e PESH A Start Time 11 30 12 07 53 53 End Time 11 30 12 08 03 43 Room temperature is too high ieee Unplug and replug Ethernet cable between PC and instrument restart the system Unplug and replug the communication cable between gateway board and GeneXpert Restart system Secure Power supply and use adapted UPS Surge protector Check Room temperature should be below 39 C Zo 18 Cepheid Confidential A Cepheid Error Messages Signal loss detected in the amplification curve 5011 GeneXpert Dx System User Data Management E Setup View Results About Check Status Cause Signal loss detected in the amplification curve Sample ID 468 13 Urmatbekova Jamily analysis Error 5011 n pss ak cted in the amplific aphasia analyte Probe B 42 3 signa onal 6 dec pe e 20 Assay X
13. pert MTB RIF G3 aoma oo Ori 1i o E Loss of tube pressure because the cartridge tube is not airtight or cartridge Other Sample Type valve is not working right Start Time 04 2513 22 16 52 End Time 04 2543 23 32 55 Status Aborted User Gasanova ie sell ss Ee CE Solution s Make sure there is no bubbles in the reaction tube Use a new cartridge If error repeats this can be module related modules fluidics are not working well Contact Cepheid support team Freaoneia 19 Cepheid Confidential Training Center Europe 33 5 63 82 5 386 378 360 training cepheidhbdc com Technical hotline Europe based 33 5 63 82 53 19 Support cepheideurope com Instrument errors Technical hotline U S A based 888 838 3222 Option 2 techsupport cepheid com Instrument errors Serial number of your GeneXpert at the back side near the power button Computer Service Express Service Tag Number Installation date of the system Pe ray eee Cepheid Thank You Visit us at www cepheidcares com PA A better way
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