BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1982003 · Received February 8, 2011

    Report

    Report Number
    2122870-2011-00342
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 10, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS LITHIUM HEPARIN PLASMA THAT WAS CENTRIFUGED FOR 15 MINUTES AT 3000 RPM. THE CUSTOMER ALIQUOTED SAMPLE PRIOR TO TESTING. THE CUSTOMER RETESTED ALL SAMPLES OF ELEVATED ACCUTNI RESULTS DURING THIS EVENT. THE CUSTOMER STATED THE INSTRUMENT PERFORMANCE WAS NOT QUESTIONED UNTIL THE ALTERNATE FACILITY OBTAINED A TROPONIN RESULT WITHIN THE NORMAL REFERENCE RANGE. SERVICE WAS ON SITE ON (B)(4) 2011 AND PERFORMED A PREVENTIVE MAINTENANCE. THE FIELD SERVICE ENGINEER (FSE) VERIFIED ULTRASONICS, ALIGNMENTS AND TRANSDUCER VOLTAGES. THE FSE PERFORMED A SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK. BOTH MET THE SPECIFICATIONS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE GENERATED BY UNICEL DXC 600I ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED A RESULT 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