BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1972093 · Received January 27, 2011

    Report

    Report Number
    2122870-2011-00131
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 29, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERA CENTRIFUGED FOR 10 MINUTES AT 3000 G. THE SAMPLES WERE ASPIRATED FROM THE PRIMARY TUBES FOR ANALYSIS AND THE APPEARANCE WAS CLEAR. A SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 AND THE RESULTS MET THE SPECIFICATIONS. THERE WAS NO ERROR OR FLAG ASSOCIATED WITH THE ERRONEOUS RESULT. DUE TO SEVERE FLOODING IN THIS AREA, THE CUSTOMER PERFORMED A PRECISION RUN AND HIGH SENSITIVITY SYSTEM CHECK WITH A BCI FIELD SERVICE ENGINEER'S DIRECTION. ALL VERIFICATION TEST RESULTS MET THE SPECIFICATIONS. NO CLEAR ROOT CAUSE FOR THIS EVENT COULD BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ELEVATED TROPONIN (ACCUTNI) RESULT ABOVE THE AMI CUTOFF GENERATED BY UNICEL DXC 600I ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT SAMPLE. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED. REPEAT TESTS ON THE SAME AND ON SUBSEQUENT SAMPLE PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THERE WAS NO 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