BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1813495 · Received August 24, 2010

    Report

    Report Number
    2050012-2010-00614
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO AND AFTER THE EVENT WAS WITHIN THE ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND A LEAK IN THE OLD STYLE PUMP AND REPLACED IT WITH A NEWER SYRINGE PUMP.

    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 OF WHICH 2 RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE RERUN ON A DIFFERENT INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. THE ORIGINAL RESULTS WERE ALL "<0.1MG/DL" AND UPON RERUN THE RESULTS WERE IN THE RANGE OF 0.71-2.92MG/DL. 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 JJE BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1