BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2032563 · Received March 29, 2011

    Report

    Report Number
    2122870-2011-00862
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    April 3, 2008
    Report Date
    April 3, 2008
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JHS
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE PLASMA COLLECTED INTO A BD PLASTIC LITHIUM HEPARIN GEL TUBE. SAMPLES WERE CENTRIFUGED VIA THE AUTOMATION LINE AND WERE TESTED USING THE PRIMARY TUBES. QC WAS IN RANGE ON EACH DAY SAMPLES WERE TESTED. SYSTEM CHECKS NOT PROVIDED. THE ISSUE REMAINS ISOLATED TO THIS ONE PATIENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2008 FOR THIS EVENT. THE FSE PERFORMED TROUBLESHOOTING AND PERFORMED ALL NECESSARY ALIGNMENTS. THE FSE VERIFIED REPAIRS PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE CUSTOMER SENT THE PATIENT'S SAMPLES TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR FURTHER TESTING. CPLS TESTING CONFIRMED THE PRESENCE A HETEROPHILE INTERFERENT, WHICH IS OBSERVED AS THE ROOT CAUSE OF THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS WITHIN THE DATE RANGE OF (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) IN REGARDS TO OBTAINING FALSELY ELEVATED CREATININE KINASE - MB (CKMB) RESULTS FOR MULTIPLE SAMPLES ON ONE PATIENT THAT WERE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE HAS BEEN NO REPORT OF PATIENT INJURY, DEATH, OR CHANGE TO TREATMENT RECEIVED TO BCI TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR