BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2082424 · Received May 10, 2011

    Report

    Report Number
    2050012-2011-01569
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 9, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND STORAGE INFORMATION WERE NOT SUPPLIED. CL QC ON THE DAY OF EVENT SHOWED ERRATIC RECOVERY. BCI FIELD SERVICE ENGINEER FOUND A LEAK IN THE ELECTROLYTE INJECTION CUP (EIC) VALVE AND REPLACED IT. FSE ALSO PERFORMED THE EIC MODIFICATION AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT FALSE HIGH CL RESULTS, GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE SAMPLES WERE TESTED ON AN ALTERNATE INSTRUMENT, WHICH GENERATED LOWER RESULTS. THESE RESULTS WERE REPORTED OUT OF THE LAB. THE FALSE HIGH CL RESULTS WERE NOT REPORTED OUT OF THE LAB AND THERE WAS NO EFFECT ON PATIENT.

    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