BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1982051 · Received February 8, 2011

    Report

    Report Number
    2122870-2011-00345
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 11, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS LITHIUM HEPARIN PLASMA THAT WAS CENTRIFUGED FOR 5 MINUTES AT 5000 RPM. THE SAMPLE WAS ASPIRATED FROM THE PRIMARY COLLECTION TUBE VIA CTA (CLOSED TUBE ALIQUOTTER). QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK WAS PERFORMED ON (B)(6) 2011 AND MET THE SPECIFICATIONS. THERE WAS NO ERROR POSTED TO THE EVENT LOG. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. 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 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