BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2032872 · Received March 29, 2011

    Report

    Report Number
    2050012-2011-00886
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 13, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC HAD BEEN RUNNING ERRATIC BUT WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT ON ALL LEVELS OF QC MATERIAL. SERVICE WAS DISPATCHED; HOWEVER, SPECIFICA SERVICE INFORMATION WAS NOT SUPPLIED. THE CUSTOMER HAS NOW BEEN UPDATED WITH THE GLUCM MODIFICATIONS FOR THE STIRRER MOTOR AND SAMPLE WHEEL COVER. ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI), AND REPORTED THAT ONE GLUCOSE (GLUCM) PATIENT RESULT RUN IN DUPLICATE MODE ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS DID NOT MATCH. THE SPECIMEN WAS RE-TESTED, IN DUPLICATE MODE, ON A DIFFERENT INSTRUMENT WHICH CONFIRMED THE HIGHER RESULT. FALSE RESULT WAS NOT REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER CGA BECKMAN COULTER INC. DXC 600 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1