BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1932293 · Received December 17, 2010

    Report

    Report Number
    2050012-2010-01548
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO AND AFTER THE EVENT WAS WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE CLEANED AN ELECTROLYTE INJECTION CUP (EIC) AND FOUND A FLAPPER ON VALVE CRACKED. THE FSE REPLACED MULTIPLE PARTS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS INTERMITTENTLY GENERATES FALSE LOW SODIUM (NA) AND FALSE HIGH CHLORIDE (CL) RESULTS. THE NA EXAMPLE, PROVIDED BY THE CUSTOMER, SHOWS THE ORIGINAL NA RESULT OF 128MMOL/L REPEATED AS 130 AND 132MMOL/L, WHICH WAS REPORTED. VERBAL CL EXAMPLES EXCEEDED ASSAY PRECISION. PER CUSTOMER, A CL RESULT OF 115MMOL/L WOULD REPEAT AS 104-107MMOL/L. NO WRONG RESULTS WERE 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 JJE BECKMAN COULTER INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1