BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1873154 · Received October 18, 2010

    Report

    Report Number
    2050012-2010-00990
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 18, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC HAD BEEN RUNNING WITHIN +/- 2SD PRIOR TO THE EVENT. WHILE WORKING WITH BCI HOTLINE, THE CUSTOMER DISCOVERED THE GLUCOSE REAGENT VOLUME WAS LOW AND DECIDED TO CHANGE TO A NEW CARTRIDGE. AFTER CHANGING THE REAGENT TO A FRESH CARTRIDGE, THE CUSTOMER RAN A SUCCESSFUL PRECISION RUN AND QC WAS RECOVERING ON THE ESTABLISHED MEAN. SERVICE CALL WAS NOT REQUESTED OR INITIATED. THE ROOT CAUSE APPEARS TO BE THE REAGENT CARTRIDGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO TWO GLUCOSE (GLU) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM THAT EXHIBITED FALSE LOW RESULTS WHEN RUN IN DUPLICATE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE OTHER PATIENT RESULTS WERE REPORTED. 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