BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2083677 · Received May 10, 2011

    Report

    Report Number
    2122870-2011-01362
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION WAS PROVIDED. NO SAMPLE COLLECTION OR PREPARATION INFORMATION WAS PROVIDED. NO QC, SYSTEM PERFORMANCE, OR CALIBRATION INFORMATION WAS PROVIDED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER WAS CONTACTED BY BECKMAN COULTER, INC. (BCI) REGARDING ACCUTNI ASSAY PERFORMANCE AND REPORTED SOME OCCURRENCES OF FALSE POSITIVE TROPONIN (ACCUTNI) RESULTS GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR UNKNOWN NUMBER OF PATIENT SAMPLES. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT ANALYSIS PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THERE WAS NO INSTANCE OF DEATH, INJURY, SERIOUS MEDICAL DETERIORATION, OR INAPPROPRIATE MEDICAL TREATMENT DUE TO THE 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1