BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2163017 · Received July 15, 2011

    Report

    Report Number
    2122870-2011-02152
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 AFTER THE EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT WITH THE DATA PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) REGARDING A LOWER THAN EXPECTED TOTAL BHCG (TBHCG) RESULT GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS QUESTIONED BY THE PHYSICIAN AS IT DID NOT MATCH THE PATIENT'S CLINICAL PRESENTATION. SUBSEQUENT DILUTION TESTING PRODUCED A HIGHER RESULT THAT INDICATED THERE IS A POTENTIAL HOOK EFFECT INTERFERING WITH THIS PATIENT'S SAMPLE. PATIENT RESULTS ARE SHOWN. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR