BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 3771923 · Received April 25, 2014

    Report

    Report Number
    2050012-2014-00214
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 5, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE FOUND A LOOSE REAGENT SYRINGE PLUNGER. THE FSE REPLACED THE BARREL ON THE LOOSE REAGENT SYRINGE. THERE WERE NO FURTHER REPORTS OF LEAKS OR OF OUT OF RANGE RESULTS DURING QUALITY CONTROL (QC.)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A UNICEL DXC 800 SYNCHRON SYSTEM PRODUCED BOTH HIGH AND LOW RESULTS FOR MULTIPLE CARTRIDGE REAGENTS DURING A QUALITY CONTROL (QC) RUN. THE CUSTOMER ALSO REPORTED LIQUID UNDER A REAGENT PROBE. THE LEAK WAS CONTAINED TO THE INSTRUMENT. THE OPERATOR WORE GLOVES AND A GOWN WHILE OPERATING THE INSTRUMENT. THERE WERE NO REPORTS OF DIRECT CONTACT WITH THE LEAK OR OF INJURY IN CONNECTION WITH THE LEAK. THE CUSTOMER REPORTS THAT TEN PATIENT RESULTS FOR MULTIPLE ANALYTES WERE AFFECTED. THESE RESULTS WERE RELEASED FROM THE LABORATORY AND WERE LATER AMENDED. THE CUSTOMER STATED THERE WAS NO CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251207 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1