BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 3083343 · Received April 29, 2013

    Report

    Report Number
    2050012-2013-00288
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE REPLACED THE REAGENT SYRING PUMP TO RESOLVE THE ISSUE. FAILURE MODE IS ATTRIBUTED TO THE CREM REAGENT SYRINGE PUMP.

    Description of Event or Problem · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS AT THE CUSTOMER'S LABORATORY TO INVESTIGATE A CC (CARTRIDGE CHEMISTRY) IMPRECISION ISSUE AND DISCOVERED THAT THE CUSTOMER GENERATED ERRONEOUSLY LOW CREM (MODULAR CREATININE) RESULTS, FOR FOUR PATIENTS, INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. THE INCORRECT RESULTS WERE REPORTED OUT OF THE LABORATORY BUT THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE FSE EVALUATED THE INSTRUMENT AND FOUND A LEAKING CREM REAGENT SYRINGE PUMP. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT BUT THE CUSTOMER WORE PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT AND NO INJURY OR EXPOSURE WAS REPORTED. THE CREM CALIBRATION, QC (QUALITY CONTROL) AND PRECISION DATA PASSED WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185544 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1