BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ...

    MDR report key: 1979585 · Received February 4, 2011

    Report

    Report Number
    2122870-2011-00192
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGE PRIOR TO AND AFTER THIS INCIDENT. THE PATIENT'S SAMPLE WAS SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR INTERFERENT TESTING. RESULTS ARE STILL PENDING TO DATE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO ROOT CAUSE COULD BE DETERMINED TO DATE FOR THIS EVENT.

    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.

    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. SUBSEQUENT SAMPLES FROM THIS PATIENT RESULTED SIMILARLY ABOVE THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. IT IS UNKNOWN IF THERE WAS ANY CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ... ... JJE BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR