BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTISOL

    MDR report key: 5535832 · Received March 30, 2016

    Report

    Report Number
    1823260-2016-00380
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    March 12, 2016
    Report Date
    April 26, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    K070788
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.BASED ON A REVIEW OF QUALITY CONTROL DATA, A GENERAL REAGENT ISSUE CAN BE EXCLUDED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED WITH BOTH CORTISOL AND CORTISOL II. THE CUSTOMER IS NOTICING A DIFFERENCE IN THE RESULTS BETWEEN THE 2 ASSAYS AND DOES NOT KNOW WHICH RESULT IS CORRECT. THE RESULTS FOR BOTH ASSAYS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL CORTISOL RESULT WAS 5.87 NMOL/L. THE INITIAL CORTISOL II RESULT WAS 115.3 NMOL/L. THESE RESULTS WERE RUN ON E602 ANALYZER WITH SERIAL NUMBER (B)(4). THE SAMPLE WAS REPEATED AND THE CORTISOL RESULT WAS 4.80 NMOL/L. THE CORTISOL II RESULT WAS 109.7. THE CORTISOL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AS 5 NMOL/L AND THE CORTISOL II RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AS 110 NMOL/L. THESE RESULTS WERE RUN ON E602 ANALYZER WITH SERIAL NUMBER (B)(4). THE CUSTOMER ALSO PROVIDED RESULTS FROM A PREVIOUS SAMPLE FROM THIS PATIENT OBTAINED ON AN UNKNOWN DATE AND THE CORTISOL RESULT WAS 9.0 NMOL/L. THE CORTISOL II RESULT WAS 114 NMOL/L. THE CUSTOMER BELIEVES THE ERRONEOUS RESULTS ARE DUE TO A PATIENT ANOMALY. NO ADVERSE EVENT OCCURRED. THE CORTISOL II ASSAY IS NOT SOLD IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192192 CORTISOL ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS NA 18538001

    Patients

    Seq Age Sex Outcome Treatment
    1