BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1636893 · Received March 22, 2010

    Report

    Report Number
    2122870-2010-00103
    Event Type
    Malfunction
    Date Received
    March 22, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    KXT
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DIGOXIN QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. SERVICE WAS OFFERED AND THE CUSTOMER DECLINED. NO ADDITIONAL INFORMATION IS AVAILABLE. 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, WITHIN THE THERAPEUTIC RANGE, FOR ONE PATIENT. A RESULT OF 0.62NG/ML, BELOW THE THERAPEUTIC RANGE, WAS OBTAINED UPON REPEAT TESTING ON A DIFFERENT INSTRUMENT. THE SPECIMEN WAS THEN RE-TESTED ON THE ACCESS 2 ANALYZER AND REPEATED RESULT MATCHED THE DIFFERENT INSTRUMENT RESULT OF 0.62NG/ML. 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