BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2008151 · Received March 4, 2011

    Report

    Report Number
    2050012-2011-00542
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 5, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DKJ
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS RUN PRIOR TO THE EVENT AND THE RESULTS WERE WITHIN ESTABLISHED RANGES. THE CUSTOMER FOUND THE SAMPLE PROBE AND COLLAR WASH CONTAINED GEL FROM THE SERUM SEPARATOR TUBE. THE CUSTOMER REPLACED THE PARTS AND REQUESTED SERVICE. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED THE FOLLOWINGS: CLEANED THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE AND COLLAR WASH. REPLACED THE CC LEVEL SENSE BEAD AND PERFORMED ALIGNMENT. RAN SAMPLE AND CONFIRMED THE CORRECT RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUS HIGH SALICYLATES RESULTS ON ONE PATIENT GENERATED BY THE UNICEL DXC 600I SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED AND LOWER RESULT WAS OBTAINED. AMENDED REPORT WAS INITIATED. PATIENT WAS ADMITTED TO THE HOSPITAL BASED ON THE FALSE HIGH RESULT. UNKNOWN IF ANY TREATMENT WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER DKJ BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization