BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 660I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 3024047 · Received March 27, 2013

    Report

    Report Number
    2050012-2013-00197
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) DECONTAMINATED THE SYSTEM, CLEANED THE FLOWCELL, AND REPLACED THE CARBON BRIDGE AND SODIUM ELECTRODE. A DEFINITIVE CAUSE FOR THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT THE UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED ERRONEOUS SODIUM (NA), CHLORIDE (CL) AND CALCIUM (CALC) RESULTS FOR THIRTEEN (13) PATIENT SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. WHEN THE ISSUE WAS NOTICED, THE CUSTOMER REANALYZED THE PATIENT SAMPLES AND ISSUED AMENDED REPORTS. IT IS UNKNOWN IF THE CUSTOMER USED THE SAME OR AN ALTERNATE INSTRUMENT FOR REANALYSIS. THE PATIENT RESULTS ARE SHOWN IN THE ATTACHMENT 1. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125518 UNICEL® DXC 660I SYNCHRON® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 660I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR