BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTISOL

    MDR report key: 5409533 · Received February 4, 2016

    Report

    Report Number
    1823260-2016-00101
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Date of Event
    January 11, 2016
    Report Date
    March 1, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    K070788
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY RESULT OF 47.6 UG/DL SUGGESTS A PATIENT SAMPLE WITH HIGH CORTISOL CONCENTRATIONS. THE HIGH RESULT OF 166.2 UG/DL FROM THE MODULAR E 170 ANALYZER CONFIRMS THIS. BASED ON A REVIEW OF THE PATIENT MEDICATIONS, NONE WERE IDENTIFIED AS INTERFERING WITH THE ASSAY, HOWEVER, IT IS NOT KNOWN HOW THE SPECIFIC MIX OF MEDICATIONS COULD AFFECT RESULTS FROM THE CORTISOL ASSAY.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CORTISOL. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER IS REQUESTING INFORMATION ON INTERFERENCES FOR THE CORTISOL ASSAY. THE INITIAL CORTISOL RESULT HAD A FLAG AND THE RESULT WAS DILUTED. THE DILUTED RESULT WAS 166.2 UG/DL. THE SAMPLE WAS SENT OUT TO A REFERENCE LABORATORY USING LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY AND THE RESULT WAS 47.6 UG/DL. NO ADVERSE EVENT OCCURRED. THE MODULAR E 170 SERIAL NUMBER WAS (B)(4). PREVENTIVE MAINTENANCE WAS PERFORMED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68725 CORTISOL ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR BACITRACIN