BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1693328 · Received May 18, 2010

    Report

    Report Number
    2050012-2010-00273
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 18, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CHH
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE. FSE REPLACED SEVERAL HARDWARE COMPONENTS AND AS OF DATE, THERE HAVE BEEN NO FURTHER ISSUES REPORTED. ALTHOUGH HARDWARE FAILURES MAY HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED TO DATE.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING INTERMITTENT ERRONEOUSLY LOW CHOLESTEROL (CHOL), TRIGLYCERIDES (TG), HDL CHOLESTEROL (HDLD) AND GLUCOSE (GLU) GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. INTERMITTENT LOW LIPID RESULTS WERE GENERATED AND REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT AND AMENDED REPORTS WERE ISSUED. THERE WAS NO IMPACT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER CHH BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1