BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS

    MDR report key: 1170258 · Received September 11, 2008

    Report

    Report Number
    2050012-2008-00051
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVENT, THE CUSTOMER ATTEMPTED TO RECALIBRATE THE ASSAY, BUT REPEATED ATTEMPTS FAILED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE REPLACED MULTIPLE PARTS, BUT THE ASSAY STILL FAILED TO CALIBRATE. THE FSE REPLACED THE ENTIRE CREM MODULE. NO ADDITIONAL INFORMATION REGARDING THIS EVENT IS AVAILABLE. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REGARDING AN ERRONEOUSLY HIGH CREATININE (CREM) RESULT THAT WAS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS FOR A SINGLE PATIENT SAMPLE. CREM RESULT OF 14.17 MG/DL WAS REPORTED OUT OF THE LAB. THE PHYSICIAN QUESTIONED THE RESULT AND CUSTOMER RE-TESTED THE ORIGINAL SAMPLE ON A DIFFERENT INSTRUMENT IN THEIR LAB AND OBTAINED A RESULT OF 1.6 MG/DL. A CORRECTED REPORT WAS SENT. PER CUSTOMER, TREATMENT WAS NOT EFFECTED BY THE ELEVATED CREM RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA