BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTISOL

    MDR report key: 5532911 · Received March 29, 2016

    Report

    Report Number
    1823260-2016-00368
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Date of Event
    February 16, 2016
    Report Date
    April 7, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    K070788
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS STATE THAT WITH THE LAUNCH OF THE CORTISOL II ASSAY, THE FORMERLY USED POLYCLONAL ANTIBODY WAS REPLACED BY A MONOCLONAL ANTIBODY, WHICH IS MORE SPECIFIC AND SHOWS A LOWER CROSS-REACTIVITY PROFILE. THE CORTISOL II ASSAY IS ALSO STANDARDIZED AGAINST DIFFERENT REFERENCE MATERIAL, WHICH ENSURES ACCURATE RESULTS. THIS STANDARDIZATION IS THE REASON THAT A SHIFT IN PATIENT RESULTS WILL BE OBSERVED WHEN SWITCHING FROM CORTISOL TO CORTISOL II.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY PERFORMED A COMPARISON STUDY FOR 30 PATIENT SAMPLES TESTED FOR CORTISOL AND CORTISOL II ON AN E170 ANALYZER. THE CUSTOMER WAS QUESTIONING RESULTS FOR ONE SAMPLE IN PARTICULAR, SINCE THERE WAS A LARGE RESULT DIFFERENCE BETWEEN THE TWO ASSAYS. OF THE PROVIDED DATA, A TOTAL OF ELEVEN PATIENT SAMPLES HAD ERRONEOUS RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY FOR CORTISOL. THE CORTISOL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND THE RESULTS FROM THE CORTISOL II ASSAY WERE BELIEVED TO BE CORRECT. THE CORTISOL II ASSAY IS NOT SOLD IN THE UNITED STATES, NOR IS IT LIKE OR SIMILAR TO PRODUCTS SOLD IN THE UNITED STATES. THE FIRST PATIENT SERUM SAMPLE INITIALLY RESULTED AS 13.7 UG/DL WHEN TESTED WITH CORTISOL. THE SAMPLE RESULTED AS 8.95 UG/DL WHEN TESTED WITH CORTISOL II. THE SECOND PATIENT SERUM SAMPLE INITIALLY RESULTED AS 10.3 UG/DL WHEN TESTED WITH CORTISOL ON (B)(6) 2016. THE SAMPLE RESULTED AS 5.42 UG/DL WHEN TESTED WITH CORTISOL II. THE THIRD PATIENT SERUM SAMPLE INITIALLY RESULTED AS 16.78 UG/DL WHEN TESTED WITH CORTISOL ON (B)(6) 2016. THE SAMPLE RESULTED AS 10.85 UG/DL WHEN TESTED WITH CORTISOL II. THE FOURTH PATIENT SALIVA SAMPLE INITIALLY RESULTED AS 2.96 NG/ML WHEN TESTED WITH CORTISOL ON (B)(6) 2016. THE SAMPLE RESULTED AS 0.54 UG/DL WHEN TESTED WITH CORTISOL II. THE FIFTH PATIENT SALIVA SAMPLE INITIALLY RESULTED AS 6.73 NG/ML WHEN TESTED WITH CORTISOL ON (B)(6) 2016. THE SAMPLE RESULTED AS 2.8 UG/DL WHEN TESTED WITH CORTISOL II. THE SIXTH PATIENT SALIVA SAMPLE INITIALLY RESULTED AS 4.13 NG/ML WHEN TESTED WITH CORTISOL ON (B)(6) 2016. THE SAMPLE RESULTED AS 1.7 UG/DL WHEN TESTED WITH CORTISOL II. THE SEVENTH PATIENT SALIVA SAMPLE INITIALLY RESULTED AS 3.67 NG/ML WHEN TESTED WITH CORTISOL ON (B)(6) 2016. THE SAMPLE RESULTED AS 1.78 UG/DL WHEN TESTED WITH CORTISOL II. THE EIGHTH PATIENT SALIVA SAMPLE INITIALLY RESULTED AS 5.67 NG/ML WHEN TESTED WITH CORTISOL ON (B)(6) 2016. THE SAMPLE RESULTED AS 2.59 UG/DL WHEN TESTED WITH CORTISOL II. THE NINTH PATIENT SALIVA SAMPLE INITIALLY RESULTED AS 14.7 NG/ML WHEN TESTED WITH CORTISOL ON (B)(6) 2016. THE SAMPLE RESULTED AS 9.49 UG/DL WHEN TESTED WITH CORTISOL II. THE TENTH PATIENT SERUM SAMPLE INITIALLY RESULTED AS 25.45 UG/DL WHEN TESTED WITH CORTISOL ON (B)(6) 2016. THE SAMPLE RESULTED AS 16.34 UG/DL WHEN TESTED WITH CORTISOL II. THE ELEVENTH PATIENT SERUM SAMPLE INITIALLY RESULTED AS 27.24 UG/DL WHEN TESTED WITH CORTISOL ON (B)(6) 2016. THE SAMPLE RESULTED AS 17.61 UG/DL WHEN TESTED WITH CORTISOL II. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE E170 ANALYZER SERIAL NUMBER WAS ASKED FOR, BUT NOT PROVIDED. INVESTIGATIONS HAVE DETERMINED THAT AN OLD CORTISOL CALIBRATION WAS IN USE AT THE TIME OF THE EVENT. NO GENERAL REAGENT ISSUE WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188853 CORTISOL ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1