BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2I (LXI) IMMUNOASSAY SYSTEM

    MDR report key: 1914241 · Received December 3, 2010

    Report

    Report Number
    2122870-2010-00846
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION WAS SUPPLIED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO ERRONEOUS ELEVATED ACCUTNL RESULT ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF FOR ONE PATIENT GENERATED BY THE ACCESS 2I (LXI) IMMUNOASSAY SYSTEM. THE INITIAL SAMPLE AND A SECOND SAMPLE WERE RERUN ON THE SAME UNIT AND RESULTS WITHIN THE NORMAL REFERENCE RANGE WERE OBTAINED FOR BOTH SAMPLES. THE RESULT WAS REPORTED OUT OF THE LABORATORY. UNKNOWN IF PATIENT TREATMENT WAS ADMINISTERED OR WITHHELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2I (LXI) IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS2 LXI

    Patients

    Seq Age Sex Outcome Treatment
    1