BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1960634 · Received January 13, 2011

    Report

    Report Number
    2122870-2011-00061
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS PLASMA. THE CENTRIFUGATION INFORMATION WAS NOT PROVIDED. QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2010. ALL VERIFICATION TESTING MET THE SPECIFICATIONS AND NO HARDWARE ISSUE WAS NOTED. THE FSE EXAMINED THE PATIENT SAMPLE TUBE IN QUESTION AND STATED THAT THERE WAS WHITE CLOUDY DEBRIS IN THE SAMPLE TUBE. THERE WAS ONLY 3/8 OF AN INCH OF PLASMA IN 13 X 100 MM GREEN TUBE. THE FSE ASPIRATED THE SAMPLE OUT AND RE-CENTRIFUGED PRIOR TO REPEAT TESTING. THREE ACCUTNI TEST RESULTS WERE 0.01 NG/ML. ALTHOUGH SAMPLE QUALITY MAY HAVE BEEN A CONTRIBUTING FACTOR, NO DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT IN THE RISK STRATIFICATION RANGE GENERATED BY UNICEL DXC 600I ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED LOWER RESULTS. THERE WAS NOT REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1