BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2120753 · Received June 10, 2011

    Report

    Report Number
    2122870-2011-01798
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED FROM THE PATIENT'S ARM AND WAS CENTRIFUGED AT 3500 RPM FOR 3 MINUTES. THE CUSTOMER NOTED THAT THE SAMPLE WAS NORMAL IN APPEARANCE. SYSTEM CHECK, CALIBRATION AND QC DATA WAS NOT SUPPLIED BY CUSTOMER. SERVICE WAS NOT DISPATCHED AS CUSTOMER SUSPECTED HETEROPHILE INTERFERENCE. CPLS CONFIRMED HETEROPHILE ANTIBODIES PRESENCE IN PATIENT SAMPLE. THEREFORE, HETEROPHILE INTERFERENCE HAS BEEN DETERMINED TO BE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING A FALSE POSITIVE TROPONIN (ACCUTNI) RESULT FOR ONE (1) PATIENT THAT DID NOT AGREE WITH THE CLINICAL PICTURE, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. THE CUSTOMER SENT THE PATIENT SAMPLE INTO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR FURTHER INVESTIGATIONAL TESTING AND INTERFERENCE TESTING. 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 JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR