BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2110786 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-02067
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WERE NOT SUPPLIED. QC WAS WITHIN ESTABLISHED RANGES BEFORE THE EVENT. BCI FIELD SERVICE ENGINEER (FSE) INVESTIGATED PRECISION ISSUES AND FOUND FLUID ON TOP OF REACTION CAROUSEL COVER AND REAGENT CAROUSEL COVER. FSE REPLACED VALVES TO ADDRESS THE PROBLEM.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED ERRONEOUS CREATININE RESULT OF 0.6 MG/DL FOR ONE (1) PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN. REPEAT TESTING GENERATED A HIGHER RESULT OF 1.2 MG/DL AND THE PATIENT REPORT WAS AMENDED. NO CHANGE TO PATIENT TREATMENT OR DIAGNOSIS WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1