BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2120626 · Received June 10, 2011

    Report

    Report Number
    2122870-2011-01840
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED FROM PATIENT'S ARM. SAMPLE WAS CENTRIFUGED AT 3500 RPM FOR 3 MINUTES. CUSTOMER NOTED THAT SAMPLE WAS NORMAL IN APPEARANCE. SYSTEM CHECK, CALIBRATION, AND QC DATA WERE NOT SUPPLIED BY CUSTOMER. PATIENT SAMPLE WAS TESTED BY CUSTOMER PRODUCT LINE SUPPORT (CPLS). RESULTS CONFIRM PRESENCE OF HETEROPHILE ANTIBODIES IN PATIENT SAMPLE. HETEROPHILE INTERFERENCE HAS BEEN DETERMINED TO BE THE ROOT CAUSE OF EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT THE ACCESS 2 IMMUNOASSAY ANALYZER GENERATED A FALSE POSITIVE TROPONIN (ACCUTNI) RESULT FOR ONE (1) PATIENT OVER AN EXTENDED PERIOD OF TIME THAT DID NOT AGREE WITH THE CLINICAL PICTURE. THE ERRONEOUS RESULT WAS REPORTED OUT SIDE THE LABORATORY. THERE WERE NO INSTANCES OF DEATH, INJURY, SERIOUS MEDICAL DETERIORATION, OR INAPPROPRIATE MEDICAL TREATMENT DUE TO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR