BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CORTISOL TEST SYSTEM

    MDR report key: 9078758 · Received September 17, 2019

    Report

    Report Number
    1823260-2019-03346
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    August 29, 2019
    Report Date
    December 12, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    K070788
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CALIBRATION SIGNALS RECOVERED SLIGHTLY LOWER THAN THE ACCEPTABLE RANGES. THE CUSTOMER QC RECOVERY WAS ACCEPTABLE. THE OBSERVED DIFFERENCES IN THE ELECSYS CORTISOL TEST SYSTEM VALUES GENERATED WITH THE ROCHE ASSAY AND LC-MS METHOD ARE MOST LIKELY CAUSED BY DIFFERENCES IN THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS, AND THE DIFFERENCES IN THE STANDARDIZATION METHODOLOGY USED. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH THE ELECSYS CORTISOL TEST SYSTEM ON A COBAS E 411 IMMUNOASSAY ANALYZER. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED WITH A CORTISOL VALUE OF 2.22 UG/L WHEN TESTED ON THE E 411 ANALYZER. WHEN REPEATED USING THE LC-MS METHOD, THE SAMPLE RESULTED WITH A VALUE OF 5.68 UG/L. THE SECOND SAMPLE INITIALLY RESULTED WITH A CORTISOL VALUE OF 2.79 UG/L WHEN TESTED ON THE E 411 ANALYZER. WHEN REPEATED USING THE LC-MS METHOD, THE SAMPLE RESULTED WITH A VALUE OF 6.15 UG/L. THE THIRD SAMPLE INITIALLY RESULTED WITH A CORTISOL VALUE OF 2.56 UG/L WHEN TESTED ON THE E 411 ANALYZER. WHEN REPEATED USING THE LC-MS METHOD, THE SAMPLE RESULTED WITH A VALUE OF 5.76 UG/L. THE RESULTS FROM THE LC-MS METHOD WERE BELIEVED TO BE CORRECT. SAMPLES WERE NOT COLLECTED IN SALIVETTE SALIVA TUBES. THE E411 ANALYZER SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872730 ELECSYS CORTISOL TEST SYSTEM ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS NA 37852000

    Patients

    Seq Age Sex Outcome Treatment
    1