BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2446598 · Received February 10, 2012

    Report

    Report Number
    2050012-2012-00353
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 18, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT CREM (CREATININE) QUALITY CONTROL ON THE UNICEL DXC 800 SYNCHRON SYSTEM WAS VERY IMPRECISE. CUSTOMER REPORTED THAT THE CREM MODULE SHOWED A CONSIDERABLE AMOUNT OF CRYSTALLIZATION ON THE SYRINGE/REAGENT PUMP AREA. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND CRYSTALS HAD FORMED ON THE CREM MODULE SYRINGE WHICH WOULD RESULT IN POOR PRECISION. THE FSE REPLACED THE SYRINGE AND CLEANED THE CUP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1