BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1890374 · Received November 3, 2010

    Report

    Report Number
    2050012-2010-01142
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 3, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN ESTABLISHED RANGES. A BCI FIELD SERVICE ENGINEER (FSE) CONFIRMED THE INSTRUMENT WAS PERFORMING TO THE SPECIFICATIONS. THE FSE NOTICED REAGENT LEVEL WAS VERY LOW AND REPLACED THE REAGENT BOTTLE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO DISCREPANT DUPLICATE GLUCOSE (GLUCM) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM FOR FOUR PATIENT SAMPLES. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER CONFIRM RESULTS BY EITHER RUNNING AGAIN ON THE SAME INSTRUMENT OR ON ANOTHER ANALYZER. THE REPORTED RESULTS WERE NOT PROVIDED. THERE WAS NO EFFECT TO THE PATIENTS OR TO THE USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1