BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2110835 · Received June 2, 2011

    Report

    Report Number
    2050012-2011-02085
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THEY HAVE HAD CREM ISSUES PREVIOUSLY. SERVICE WAS DISPATCHED ON (B)(4) 2011 AND REPLACED THE DRAIN VALVE FOR SLOW DRAINAGE ISSUES.QC WAS WITHIN ESTABLISHED LIMITS AFTER THE EVENT.A FIELD SERVICE (FSE) WAS DISPATCHED AND FOUND A PREVIOUS SPILL IN THE MODULE. THE FSE REPLACED THE CREATININE MODULE DO TO THE ONGOING IMPRECISION. THE FSE ALSO PERFORMED ALIGNMENTS, PRIMED, AND CALIBRATED THE LAMP.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER CREATININE (CREM) MODULE REPORTED AN ERRONEOUSLY HIGH PATIENT RESULT.THE ORIGINAL RESULT WAS 7.3 MG/DL. THE RESULT WAS QUESTIONED BY THE NURSE AND WAS REPEATED AND FOUND TO BE 0.8 MG/DL.PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1