BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1711212 · Received June 4, 2010

    Report

    Report Number
    2050012-2010-00321
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 18, 2010
    Report Date
    June 4, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JFY
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE. FSE EVALUATED THE SYSTEM, REPLACED SOME HARDWARE AND THE SYSTEM WAS RESUMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING MULTIPLE LOW CREATININE (CRE) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE SAMPLES WERE RERUN AND GAVE HIGHER RESULTS. THERE WAS NO AFFECT 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 JFY BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1