BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS

    MDR report key: 1810389 · Received August 20, 2010

    Report

    Report Number
    2050012-2010-00582
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRE AND POST EVENT WAS WITHIN 1 SD OF THE MEAN. A BCI FIELD SERVICE ENGINEER (FSE) CLEANED THE SAMPLE MIXER WASH STATION INSERT. FSE ALSO REPLACED SAMPLE AND REAGENT MIXERS. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FROM THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO ERRONEOUSLY HIGH MAGNESIUM (MG) RESULTS GENERATED BY UNICEL DXC 800 PRO CLINICAL SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. ONE PHYSICIAN QUESTIONED A HIGH MG RESULT, WHICH CAUSED THE LAB TO REPEAT THAT RESULT AND OTHER MG RESULTS FROM THAT DAY. UNKNOWN IF PATIENT TREATMENT WAS IMPACTED BY THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1