BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2030076 · Received March 25, 2011

    Report

    Report Number
    2122870-2011-00818
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN LITHIUM HEPARIN PLASMA GEL TUBES OF 12 X 75MM, AND CENTRIFUGED AT 8000 RPM FOR 3 MINUTES. NO EVENT LOG MESSAGES OR SYSTEM FLAGS WERE ASSOCIATED WITH THIS EVENT. SERVICE WAS NOT DISPATCHED BECAUSE THE CUSTOMER WOULD BE USING THEIR IN-HOUSE BIOMED ENGINEER. THE BIOMED ENGINEER DID NOT IDENTIFY ANY HARDWARE ISSUES WITH THE INSTRUMENT. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A NON-REPRODUCIBLE FALSE POSITIVE TROPONIN (ACCUTNI) RESULT GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. REPEAT ANALYSIS PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RAGE. THE RESULTS ARE SHOWN. THERE WAS NO REPORT OF DEATH, INJURY, SERIOUS MEDICAL DETERIORATION, OR INAPPROPRIATE MEDICAL TREATMENT CONNECTED TO THIS 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1