BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2248938 · Received September 15, 2011

    Report

    Report Number
    2050012-2011-04961
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 15, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE AND AFTER THIS INCIDENT AND THE RESULTS WERE WITHIN ESTABLISHED RANGES. TECHNICAL APPLICATIONS INFORMED THE CUSTOMER THAT THE DATA SUGGESTS THE PRESENCE OF INTERFERENCE IN THE SAMPLE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING A PATIENT SAMPLE THAT WAS RUN ON THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER THAT YIELDED A SUPPRESSED OUT OF INSTRUMENT RANGE (OIR) LOW HIGH DENSITY LIPOPROTEIN DEFICIENCY (HDLD) RESULT. THE CUSTOMER ALSO RAN THE SAMPLE ON AN ALTERNATE INSTRUMENT AND GOT THE SAME SUPPRESSED OIR LOW RESULT. THE CUSTOMER REPORTED A RESULT OF < 5 MG/DL ON (B)(6) 2011. THE CUSTOMER SENT THE SAMPLE TO TWO DIFFERENT REFERENCED LABORATORIES ON (B)(6) 2011 AND THE RESULTS YIELDED 32 MG/DL AND 34 MG/DL. THE CUSTOMER AMENDED THE AVERAGED VALUE OF 33 MG/DL. THE CUSTOMER THAN RERAN THE RESULTS ON THE SAME INSTRUMENTS (THE DXC 800 PRO AND THE ALTERNATE INSTRUMENT) ON (B)(6) 2011 TO RECONFIRM THE RESULTS AND GENERATED THE SAME SUPPRESSED OIR LOW RESULTS. THERE WAS NO CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1