BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2022836 · Received March 17, 2011

    Report

    Report Number
    2050012-2011-00787
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER ANALYTES RUN WITH THE FIRST SAMPLE GAVE ALL SUPPRESSED RESULTS. WHEN RERUN ALL RECOVERED ACCEPTABLE RESULTS. SAMPLING WAS DONE FROM THE PRIMARY TUBE FOR FIRST RUN. THE SAMPLE WAS POURED INTO A NESTED CUP ON REPEAT RUN. A FIELD SERVICE ENGINEER (FSE) VERIFIED WITH THE CUSTOMER THE EVENT WAS SAMPLE SPECIFIC. HARDWARE WAS VERIFIED AS RUNNING TO ESTABLISHED SPECIFICATIONS. ROOT CAUSE APPEARS TO BE A SHORT SAMPLE.

    Description of Event or Problem · 1

    BECKMAN COULTER INC., (BCI) INTERNAL MONITORING DATA FOR GLUCOSE (GLUCM) PHASE I INDICATED THAT ONE PATIENT DID NOT MATCH WHEN RUNNING IN DUPLICATE MODE ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. ONE GLUCM SAMPLE RESULT OF 3MG/DL WAS OBTAINED AND THEN RUN IN DUPLICATE MODE YIELDED A RESULT OF 92MG/DL AND WAS REPORTED. CUSTOMER DID NOT CALL AND COMPLAIN TO BCI ABOUT THIS SAMPLE. NO ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1