BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1172880 · Received September 19, 2008

    Report

    Report Number
    2122870-2008-00299
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS RUN TWICE DAILY AND WAS IN RANGE BEFORE THE EVENT. NO FLAGS OR EVENT LOG MESSAGES WERE GENERATED AT THE TIME OF THE EVENT. THE SPECIMEN WAS COLLECTED IN A GREINER 13X100MM SERUM SST TUBE, AND WAS CENTRIFUGED AT 2,200 RCF FOR 10 MINUTES. PER CUSTOMER, SAMPLE APPEARED TO BE OF "GOOD QUALITY". A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED AS CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE. A CLEAR ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION SUPPLIED. 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 TROPONIN (ACCU TNI) RESULT THAT WAS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR A SINGLE PATIENT SAMPLE. THE INITIAL RESULT WAS 18.66NG/ML. THE RESULT WAS NOT REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLE WAS RETESTED AND A RESULT OF 0.06NG/ML WAS OBTAINED. THE SAMPLE WAS RE-TESTED ONCE MORE AND A RESULT OF 0.06NG/ML WAS REPORTED OUT OF THE LAB. THERE WAS NO EFFECT TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA