BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2940424 · Received February 3, 2013

    Report

    Report Number
    2050012-2013-00057
    Event Type
    Malfunction
    Date Received
    February 3, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY LOW AND SUPPRESSED RESULTS FOR VARIOUS CARTRIDGE CHEMISTRIES (CC) FOR MULTIPLE PATIENTS INVOLVING A UNICEL DXC 600 SYNCHRON SYSTEM ON (B)(6) 2013. THE CUSTOMER PROVIDED INSTRUMENT PRINTOUTS FOR FIVE PATIENT SAMPLES WHICH SHOW SUPPRESSED OR VERY LOW RESULTS FOR SEVERAL CHEMISTRIES INCLUDING ALBUMIN (CLB), ALKALINE PHOSPHATASE (ALP), ALANINE AMINOTRANSFERASE (ALT), ASPARTATE AMINOTRANSFERASE (AST), CREATININE (CR-S), GLUCOSE (GLU), HIGH DENSITY LIPOPROTEIN (HDLD), PHOSPHOROUS (PHS), TOTAL BILIRUBIN (TBIL), TOTAL PROTEIN (TP), AND UREA NITROGEN (BUN). INCORRECT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO AFFECT OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER HAD STOPPED RUNNING THE ANALYZER UNTIL THE INSTRUMENT WAS SERVICED. THE CUSTOMER NOTED THAT QUALITY CONTROL (QC) RESULTS WERE ALSO BELOW THE ACCEPTABLE RANGES. QC PRINTOUTS PROVIDED FOR THREE LEVELS OF PHENYTOIN (PHY), WHICH WAS RUN AFTER THE INCORRECT RESULTS WERE GENERATED, INDICATED THAT 2 LEVELS WERE GREATER THAN 3 STANDARD DEVIATIONS LOW. THE CUSTOMER NOTED THAT QC HAD BEEN RUN PRIOR TO OBTAINING THE INCORRECT RESULTS BUT PRINTOUTS WERE NOT PROVIDED. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON THE SAME DAY AND FOUND TUBING FROM THE CC SAMPLE LEVEL SENSE BEAD TO THE OBSTRUCTION DETECTOR (ODC) HAD SPLIT AND WOULD LEAK WHEN PRIMED. THE FSE REPLACED THE TUBING AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE WAS DETERMINED TO BE A SPLIT TUBING AND ISSUE WAS RESOLVED FOLLOWING SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45721 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1