BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® SYSTEM

    MDR report key: 3781678 · Received April 30, 2014

    Report

    Report Number
    2050012-2014-00232
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE REPLACED THE ISE DRAIN WASTE VALVE. THERE WERE NO FURTHER REPORTS OF DRAIN OVERFLOW OR OF ERRONEOUS NA, CL, AND CALCIUM RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LABORATORY INFORMATION SYSTEM FLAGGED RESULTS FOR SODIUM (NA), CHLORIDE (CL), AND/OR CALCIUM (CA) FOR TEN PATIENTS AS ERRONEOUS ON A UNICEL DXC 800 PRO SYNCHRON SYSTEM. WHILE TROUBLESHOOTING THE INSTRUMENT WITH BECKMAN COULTER (BEC) HOTLINE SUPPORT, THE CUSTOMER REPORTED AN OVERFLOW FROM THE ISE DRAIN. THE LEAK WAS CONTAINED TO THE INSTRUMENT. THE CUSTOMER WORE GLOVES, GOWN, AND EYE PROTECTION WHILE OPERATING THE INSTRUMENT. THERE WAS NO REPORT OF DIRECT CONTACT WITH THE LEAK OR OF INJURY AS A RESULT OF THE LEAK. ERRONEOUS RESULTS WERE RELEASED FROM THE LABORATORY. PATIENT SAMPLES WERE LATER RERUN AND AMENDED RESULTS WERE REPORTED TO THE PHYSICIAN. THE WAS NO IMPACT TO PATIENT TREATMENT OR REPORT OF INJURY OR DEATH AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259844 UNICEL® DXC 800 PRO SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1