BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1062401 · Received June 17, 2008

    Report

    Report Number
    2122870-2008-00190
    Event Type
    Other
    Date Received
    June 17, 2008
    Date of Event
    May 25, 2008
    Report Date
    June 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A BD LITHIUM HEPARIN TUBE WITH A GEL SEPARATOR AND WAS CENTRIFUGED AT 3000 RPM FOR 6 MINS. BD RECOMMENDS A SPIN TIME OF 10 MINS. PER CUSTOMER, THERE WAS A FIBRIN CLOT ABOVE THE GEL BARRIER IN THE PLASMA. A SYSTEM CHECK PERFORMED IN 2008 FAILED PARTIALLY AND PASSED UPON 2ND REPEAT. QC LEVEL II HAD TO BE REPEATED THREE TIMES TO GET THE QC IN RANGE BEFORE THE EVENT. AFTER THE EVENT QC LEVEL II WAS REPEATED TWICE TO GET THE QC IN RANGE. A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER'S LAB, BUT SERVICE INFO WAS NOT SUPPLIED. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED 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 ELEVATED ACCUTNI RESULT GENERATED BY THE UNICEL. DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR A SINGLE PT. AN INITIAL ACCU TNI RESULT WAS 14.41 NG/ML. THE RESULT WAS NOT REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLE WAS RETESTED TWICE FOR ACCU TNI AND 2 RESULTS OF 0.07 NG/ML WERE OBTAINED. THE RESULT OF 0.07NG/ML WAS REPORTED OUT OF THE LAB. THERE HAS BEEN NO REPORT OF DEATH, INJURY, OR CHANGE TO PT TREATMENT IN ASSOCIATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA