BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CORTISOL II

    MDR report key: 6999784 · Received November 3, 2017

    Report

    Report Number
    1823260-2017-02525
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 19, 2017
    Report Date
    January 8, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFT
    PMA / PMN Number
    K152227
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION DETERMINED THERE WAS NO INTERFERENCE BETWEEN OXYCODONE AND THE ELECSYS CORTISOL II ASSAY.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS CORTISOL II RESULTS AND SUSPECTED INTERFERENCE DUE TO OXYCODONE. THE PATIENT HAD CORTICOTROPIC INSUFFICIENCY, WAS HOSPITALIZED, AND WAS TREATED WITH HYDROCORTISONE (HC) AND OXYCODONE. THE CORTISOL RESULT (12H) WAS 122 NMOL/L FOLLOWING INTAKE OF 15 MG OF HYDROCORTISONE (HC) AT 8:44. THE ENDOCRINOLOGIST DID NOT BELIEVE THE RESULT MATCHED THE CLINICAL PICTURE FOR THE PATIENT AND ASKED FOR TESTING BY HPLC/SM. THE RESULT WAS 42 NMOL/L. THE CORTISOL RESULT (16H) WAS 124 NMOL/L FROM THE COBAS 8000 E 602 MODULE AND 128 NMOL/L BY HPLC. THE CUSTOMER DETERMINED IF 15 MG OF OXYCODONE IS TAKEN AT 8:30 AM, ITS MAXIMUM PEAK WOULD BE REACHED IN 3 HOURS WHICH CORRESPONDS TO THE (12H) TESTING AND THE HALF-LIFE ELIMINATION OF THE COMPOUND IS APPROXIMATELY 4 HOURS, WHICH CORRESPONDS TO THE (16H) TESTING. AS THE PATIENT ALSO HAD A CORTISOL RESULT OF 342 NMOL/L WHICH WAS ASSESSED BY THE CUSTOMER TO NOT BE TOO HIGH, AN INTESTINAL MALABSORPTION OR ACCELERATED METABOLISM WAS ASSUMED FOR THE PATIENT. THE DATE AND TIME OF THIS TESTING WAS REQUESTED BUT WAS NOT PROVIDED. INFORMATION CONCERNING IF THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED BUT THIS INFORMATION WAS UNKNOWN. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER USED A COBAS 8000 E 602 MODULE SERIAL NUMBER (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781224 ELECSYS CORTISOL II FLUOROMETRIC, CORTISOL JFT ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1