BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1650943 · Received April 5, 2010

    Report

    Report Number
    2122870-2010-00129
    Event Type
    Malfunction
    Date Received
    April 5, 2010
    Date of Event
    March 9, 2010
    Report Date
    April 5, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    KXT
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE SERUM COLLECTED IN SST TUBES AND CENTRIFUGED AT 3,000 RPM FOR 5 MINUTES. THE ORIGINAL TESTING WAS PERFORMED FROM THE PRIMARY TUBES THROUGH THE CTA. THE SPECIMENS WERE ALIQUOTED AND RE-CENTRIFUGED BEFORE THE REPEAT TESTING.NO QC ISSUES WERE NOTED IN THIS EVENT. TWO SYSTEM CHECKS PERFORMED ON (B)(6)2010 AND (B)(6)2010 MET SPECIFICATIONS.NO ERRORS WERE POSTED TO THE EVENT LOG DURING THE TIME OF THIS EVENT.SERVICE WAS OFFERED AND DECLINED BY THE CUSTOMER.A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED DIGOXIN RESULTS ABOVE THE THERAPEUTIC RANGE ON TWO PATIENTS' SAMPLES.THE RESULT FOR THE 1ST PATIENT WAS REPORTED OUT OF THE LAB AND IT WAS QUESTIONED BY THE PHYSICIAN.UPON REPEAT TESTING, LOWER DIGOXIN RESULTS WERE OBTAINED FOR BOTH PATIENTS.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 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER KXT BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1