BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 3122457 · Received May 21, 2013

    Report

    Report Number
    2050012-2013-00351
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) PRIOR TO THE EVENT WAS WITHIN LABORATORY ESTABLISHED RANGES (NEAR THE MEAN), BUT QC EARLIER IN THE DAY HAD BEEN 4 MMOL/L LOWER THAN THE MEAN. THE CUSTOMER HAD MENTIONED LOW PATIENT RECOVERY EARLIER IN THE DAY, BUT ALL THE PRINTOUTS PROVIDED WERE OF HIGH RECOVERY. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND A BUBBLE ON THE FACE OF THE NA ELECTRODE. THE FSE REMOVED THE BUBBLE FROM THE ELECTRODE AND DECONTAMINATED THE IONIZED SELECTIVE ELECTRODE (ISE) SYSTEM. FAILURE MODE IS UNKNOWN. ALTHOUGH THE FSE NOTED AND REMOVED A BUBBLE FROM THE FACE OF THE ELECTRODE, A CONTAMINATED SYSTEM COULD ALSO HAVE CAUSED THE NA DRIFT SYMPTOM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED FALSE SODIUM (NA) RESULTS FOR FIFTY (50) TO SIXTY (60) PATIENT SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE ISSUE STARTED WITH MULTIPLE SAMPLES RECOVERING ABOUT 130 MMOL/L, AT WHICH TIME THE CUSTOMER RECALIBRATED AND RERAN SAMPLES. THIS TIME, NA RECOVERY WAS HIGH. THE CUSTOMER PROVIDED PRINTOUTS OF HIGH NA RESULTS FROM THIRTEEN (13) SAMPLES. THE CUSTOMER IS ONLY QUESTIONING THE NA RESULTS. PATIENT TREATMENT WAS NOT IMPACTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224665 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1