BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CORTISOL II

    MDR report key: 23606622 · Received November 20, 2025

    Report

    Report Number
    1823260-2025-04742
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 28, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFT
    PMA / PMN Number
    K152227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE E411 ANALYZER SERIAL NUMBER WAS (B)(6).

    Additional Manufacturer Narrative · 0

    QC WAS ACCEPTABLE. THE CUSTOMER BELIEVES THE LOW RESULT WAS DUE TO HOW THE SAMPLE WAS PLACED ON THE INSTRUMENT; THE CUSTOMER HAS HAD NO FURTHER ISSUES. THE CUSTOMER DECLINED AN INVESTIGATION. AS NO FURTHER INFORMATION WAS RECEIVED, THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CORTISOL II (CORTISOL II) ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 3.9 NMOL/L. ON (B)(6) 2025, THE REPEAT RESULT WAS 125 NMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2578484 ELECSYS CORTISOL II FLUOROMETRIC, CORTISOL JFT ROCHE DIAGNOSTICS 85587501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown