BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2001942 · Received February 27, 2011

    Report

    Report Number
    2050012-2011-00536
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO CALIBRATION OR QC PROBLEMS PRIOR TO THE EVENT. BECKMAN COULTER FIELD SERVICE HAS BEEN MONITORING THIS ACCOUNT.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) INTERNAL MONITORING DATA FOR GLUCOSE (GLU) INDICATED ONE PATIENT RESULT GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM THAT DID NOT MATCH WHEN RUNNING IN DUPLICATE MODE. THE INITIAL GLU RESULT WAS 90MG/DL WHICH REPEATED AT 60MG/DL. THE CUSTOMER REPORTED THE RESULT OF 90MG/DL. THE CUSTOMER DID NOT CALL OR COMPLAIN TO BCI ABOUT THIS EVENT. THERE WAS NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1