BEUDAMED
    FDA Adverse Event Summary report: N

    ACCESS 2I (LXI) IMMUNOASSAY SYSTEM

    MDR report key: 1914174 · Received December 3, 2010

    Report

    Report Number
    2122870-2010-00845
    Date Received
    December 3, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM AND COLLECTED IN THE ER. THE SAMPLES WERE CENTRIFUGED FOR 5 MINUTES AT 4000 RPM. THE COLLECTION TUBES ARE LOADED AND PROCESSED THROUGH THE CLOSE TUBE ACCESSION. ON (B)(4) 2010, THE CUSTOMER PERFORMED SYSTEM CHECK WHICH MET SPECIFICATIONS. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED PREVENTIVE MAINTENANCE AND VERIFIED ALL TESTING MET SPECIFICATIONS. FSE DID NOT NOTE ANY HARDWARE ISSUES ASSOCIATED WITH THIS EVENT. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FRO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS ELEVATED ACCUTNI 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. THE INITIAL SAMPLE RESULT WAS WITHIN THE RISK STRATIFICATION RANGE AND THE SECOND SAMPLE RESULT WAS WITHIN NORMAL REFERENCE RANGE. 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 JJE BECKMAN COULTER INC. ACCESS2 LXI

    Patients

    Seq Age Sex Outcome Treatment
    1