BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2003332 · Received March 1, 2011

    Report

    Report Number
    2122870-2011-00480
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL THREE LEVELS OF BHCG QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND ON THE DAY OF THE EVENT. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2011 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED TROUBLESHOOTING AND ADDRESSED MULTIPLE HARDWARE ISSUES. THE FSE REPLACED MULTIPLE PARTS, PERFORMED CLEANING OF SOME HARDWARE COMPONENTS AND PERFORMED ALIGNMENTS. THE FSE PERFORMED A SPECIAL CLEAN, CARRYOVER TEST AND A HIGH SENSITIVITY SYSTEM CHECK; NO ISSUES WERE NOTED. ALTHOUGH FSE ADDRESSED MULTIPLE HARDWARE ISSUES, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING A HIGHER THAN EXPECTED POSITIVE TOTAL BHCG (TBHCG) RESULT, ABOVE THE NORMAL REFERENCE RANGE, GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING PRODUCED LOWER POSITIVE RESULTS WHICH BETTER MATCHED THE PATIENT'S CLINICAL PRESENTATION. THE RESULTS WERE REPORTED OUT OF THE LAB. THE EFFECT, IF ANY, TO THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1