BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1979562 · Received February 4, 2011

    Report

    Report Number
    2122870-2011-00327
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER PRODUCT LINE SUPPORT (CPLS) STATED THAT CORTISOL AND HYDROCORTISOL ARE LABELED AS THE SAME MOLECULE. SINCE HYDROCORTISOL IS THE SAME MOLECULE AS CORTISOL, THERE WOULD BE NO CROSS REACTIVITY AND/OR INTERFERENCE. BASED ON THE INFORMATION GATHERED, THE MDR IS CLASSIFIED AS USER ERROR AND NOT A MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THE SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT PROVIDED. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. THE PATIENT'S SAMPLE WAS SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING. RESULTS ARE PENDING. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. 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) IN REGARDS TO OBTAINING A HIGHER THAN EXPECTED CORTISOL RESULT FOR ONE PATIENT'S SAMPLE THAT WAS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE ORIGINAL SAMPLE RESULT WAS 96.0 (NMOL/L). SUBSEQUENT SAMPLES FROM THIS PATIENT RESULTED SIMILARLY ABOVE THE NORMAL REFERENCE RANGE. UNKNOWN IF PATIENT TREATMENT WAS WITHHELD OR ADMINISTERED BASED ON THE HIGH CORTISOL RESULTS.

    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. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR