BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2180189 · Received July 27, 2011

    Report

    Report Number
    2122870-2011-02439
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT DATA GENERATED. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED. QUALITY CONTROL RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. THE CUSTOMER IS NOT QUESTIONING THE RESULTS OBTAINED FROM OTHER PATIENT SAMPLES. THE CUSTOMER IS NOT QUESTIONING THE PERFORMANCE OF OTHER ASSAYS ON THE ANALYZER. THIS MEDWATCH REPORT IS RELATED TO ANOTHER MEDWATCH REPORT FILED FOR DISCREPANT CK-MB RESULTS FOR THE SAME PATIENT BUT FOR A DIFFERENT SPECIMEN DRAWN AND ASSAYED ON ANOTHER DAY. REFER TO MEDWATCH REPORT NUMBER 2122870-2011-02438.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT DISCREPANT RESULTS FOR CREATINE KINASE - MB (CK-MB) FOR ONE (1) PATIENT SAMPLE ASSAYED WITH ACCESS CK-MB REAGENT ON A UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THE DISCREPANT CK-MB RESULTS WERE REPORTED OUT OF THE LABORATORY. ON (B)(6) 2011, THE CUSTOMER REPORTED AN ABNORMALLY HIGH CK-MB RESULT FOR THE PATIENT. LATER THAT DAY, THE SAME SPECIMEN WAS RE-ASSAYED FOR CK-MB. THE CUSTOMER REPORTED TWO (2) CK-MB RESULTS WHICH WERE DISCREPANTLY LOWER THAN THE INITIAL RESULT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE ON (B)(6) 2011. THE FSE OBSERVED NO UNUSUAL ERRORS POSTED TO THE EVENT LOG OF THE ANALYZER DURING THE TIME OF THE EVENT. THE FSE PERFORMED A SYSTEM CHECK OF THE ANALYZER WHICH MET ALL PERFORMANCE SPECIFICATIONS. THE FSE REPORTED THAT THE CUSTOMER HAD RERAN MULTIPLE PATIENT SAMPLES IN DUPLICATE WITH NO DISCREPANT RESULTS OBSERVED. THE FSE REPORTED THAT "THE ONLY PROBLEM OBSERVED IS WITH A SINGLE PATIENT." A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXI 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR ACCESS CK-MB REAGENT