BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2142021 · Received June 28, 2011

    Report

    Report Number
    2050012-2011-02494
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ERRONEOUS RESULTS GENERATED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT ERRONEOUSLY HIGH MICROALBUMIN (MA) RESULTS FOR 4 PATIENT SAMPLES ASSAYED ON THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPORTED THERE WAS NO CHANGE TO PATIENT TREATMENT BASED ON THE ERRONEOUS MA RESULTS. THE CUSTOMER REPORTED THAT THE QUALITY CONTROL RESULTS FOR MA WERE ERRATIC. A PRECISION ANALYSIS (PERFORMED WITH 10 ASSAYS ON A PATIENT SAMPLE) YIELDED A FIRST MA RESULT WHICH WAS 70% HIGH. NO ISSUES WITH OTHER CHEMISTRIES OR SYSTEM ERRORS WERE REPORTED BY THE CUSTOMER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE ON (B)(4) 2011. THE FSE REPLACED THE SAMPLE PROBE, WASH COLLAR, AND 3-WAY VALVE TO ADDRESS CARRYOVER THAT WAS OBSERVED ON THE ANALYZER. THE FSE ALSO ALIGNED THE PROBE AND CUVETTE. THE FSE ASSAYED 4 PATIENT SAMPLES FOR MA IN TRIPLICATE. ALL RESULTS GENERATED WERE REPRODUCIBLE AND ACCURATE. AMENDED REPORTS FOR THE 4 PATIENT SAMPLES INITIALLY TESTED WERE SENT OUT. THE ROOT CAUSE FOR THIS EVENT IS ATTRIBUTABLE TO ROUTINE REPAIRS PERFORMED ON THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROALBUMIN REAGENT