BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS

    MDR report key: 1000515 · Received February 13, 2008

    Report

    Report Number
    2050012-2008-00008
    Event Type
    Malfunction
    Date Received
    February 13, 2008
    Date of Event
    January 17, 2008
    Report Date
    February 13, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED IN BD, PLASTIC LITHIUM HEPARIN WITH GEL SEPARATOR TUBES. QC WAS PERFORMED BEFORE AND AFTER THE EVENT AND WAS WITHIN SPECS. A FIELD SVC ENGINEER (FSE) CONTACTED THE CUSTOMER ON 01/29/08: THE FSE HAD THE CUSTOMER PERFORM A PRECISION RUN AND THE INSTRUMENT VERIFICATION PASSED. SVC HAS VERIFIED THE INSTRUMENT PERFORMANCE. AS OF 02/05/08, NO ADD'L EVENTS HAVE BEEN REPORTED BY THE CUSTOMER. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE LOW POTASSIUM (K) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYS. PT A AND B SAMPLES WERE TESTED FOR K AND RESULTS WERE: 4.7MMOL/L FOR PT AND 4.0MMOL/L FOR PT B. THE ORIGINAL SAMPLES WERE RE-TESTED FOR K AND HIGHER RESULTS WERE OBTAINED : 5.7 MMOL/L FOR PT A AND 5.0MMOL/L FOR PT B. IT IS UNK IF TREATMENT WAS INITIATED OR WITHHELD BASED UPON THE FALSE LOW K RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA