BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3034055 · Received April 3, 2013

    Report

    Report Number
    2050012-2013-00246
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLES ARE COLLECTED IN LITHIUM HEPARIN TUBES, CENTRIFUGED FOR 6 MINUTES AT 3,600 RPM, AND STORED AT ROOM TEMPERATURE FOR A RANGE OF 30 MINUTES TO 2 HOURS. QUALITY CONTROL (QC) ON THE DAY OF EVENT WAS WITHIN LAB-ESTABLISHED RANGES. PATIENT CONTROLS WERE OUT OF RANGE LOW, BUT THE OPERATORS FAILED TO NOTICE AND CONTINUED TO RUN PATIENT SAMPLES. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT, BUT FOUND NO EVIDENCE OF AN INSTRUMENT MALFUNCTION. IONIZED SELECTIVE ELECTRODE (ISE) HEALTH CHECKS PASSED WITHIN SPECIFICATIONS. THE FSE MENTIONED THAT THE CALIBRATORS AND CONTROLS HAD BEEN POURED OFF INTO CUPS AND SAT FOR A LENGTH OF TIME PRIOR TO BEING ANALYZED. THE CUSTOMER CONFIRMED THAT THEY HAD BEEN RUN ON THE OTHER INSTRUMENT WITHIN THE LABORATORY, AND THEN SAT PARAFILMED IN THE POURED OFF CUPS FOR 3 HOURS PRIOR TO BEING USED ON THE REPORTED INSTRUMENT. DEVELOPMENT ANALYZED THE DATA, WHICH SHOWS THAT THE CALIBRATION NUMBERS FOR BOTH ISE AND GLUCOSE WERE NOT AS EXPECTED AND CORRELATE WITH THE CALIBRATOR HANDLING. THE SYSTEM CALIBRATED TO A CONCENTRATED CALIBRATOR (DUE TO EVAPORATION), WHICH EXPLAINS THE LOW RECOVERY FOR PATIENT SAMPLES. THE CONTROLS WERE ALSO COMPROMISED, SO APPEARED TO RECOVER CORRECTLY DUE TO THE CALIBRATION. ADDITIONAL INVESTIGATIONAL DATA SHOWS THAT ALL PATIENT SAMPLES RUN AFTER THIS CALIBRATION WERE LOW, INCLUDING THE PATIENT CONTROL THAT WAS IGNORED BY THE OPERATOR. RECALIBRATION RESOLVED THE ISSUE. FAILURE MODE IS USE ERROR. THE FOLLOWING TWO (2) MDRS ARE ALSO ASSOCIATED WITH THIS EVENT TO DOCUMENT THE OTHER TWO (2) PATIENTS WHO HAD IMPACT ON PATIENT TREATMENT: 2050012-2013-00244, 2050012-2013-00245.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) STATING THAT THE UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM WAS GENERATING FALSE LOW SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), CARBON DIOXIDE (CO2), CALCIUM (CA), AND/OR GLUCOSE (GLUM MODULAR) RESULTS FOR TWENTY-TWO (22) PATIENT SAMPLES. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE LOW RESULTS STARTED DURING THE 1ST SHIFT. THE LABORATORY RUNS A PATIENT CONTROL EACH SHIFT. ON THE 2ND SHIFT, THE PATIENT CONTROL WAS LOW (AT 126 MMOL/L), BUT THE OPERATOR FAILED TO CHECK THE PREVIOUS RESULT FOR ACCEPTABILITY. PATIENTS WERE RECOVERING LOW, BUT THE OPERATOR DIDN'T NOTICE/TAKE ANY ACTIONS AT THAT TIME. ON 3RD SHIFT, THE PATIENT CONTROL MATCHED THE RESULTS FROM THE 2ND SHIFT, AND NO ACTIONS WERE IMMEDIATELY TAKEN. WHEN THE ISSUE WAS NOTICED, THE SYSTEM WAS RECALIBRATED AND SAMPLES RERUN. THE RESULTS WERE AMENDED TO THE REPEAT PATIENT RESULTS. THREE (3) OUT OF THE TWENTY-TWO (22) PATIENTS HAD CHANGE TO PATIENT TREATMENT DUE TO THE INITIAL FALSE LOW RESULTS. THIS REPORT DOCUMENTS ONE (1) OF THE THREE (3) PATIENTS WHO WERE IMPACTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A FALSE LOW NA RESULT THAT WAS OBTAINED. NO TREATMENT WAS GIVEN UPON ADMITTANCE TO THE HOSPITAL. THE PATIENT WAS RELEASED AS SOON AS THE RESULT WAS AMENDED TO THE REPEATED RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136533 UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER DXC 660I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization