BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1664901 · Received April 22, 2010

    Report

    Report Number
    2122870-2010-00156
    Event Type
    Malfunction
    Date Received
    April 22, 2010
    Date of Event
    March 26, 2010
    Report Date
    April 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    KXT
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A PST TUBE AND CENTRIFUGED AT 3,800 RPM FOR 10 MINUTES. PER CUSTOMER, THE SAMPLE APPEARED CLEAR.DIGOXIN QC WAS WITHIN THE SPECIFICATIONS PRIOR TO THE EVENT. NO ERRORS WERE POSTED TO THE EVEN LOG.SERVICE WAS OFFERED; HOWEVER, THE CUSTOMER PREFERRED TO CONFIRM HARDWARE PERFORMANCE BY PERFORMING A SYSTEM CHECK, WHICH PASSED. CUSTOMER THEN DECLINED SERVICE.NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED AN ERRONEOUS DIGOXIN RESULT, ABOVE THE THERAPEUTIC REFERENCE RANGE, FOR ONE PATIENT.UPON REPEAT, THE RESULTS WERE IN THE NORMAL REFERENCE RANGE. THE ORIGINAL SPECIMEN WAS TESTED AT THE REFERENCE LAB AND OBTAINED RESULT CORRELATED WITH THE REPEATED RESULTS.THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LAB. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1