BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CORTISOL II

    MDR report key: 19743113 · Received July 15, 2024

    Report

    Report Number
    1823260-2024-02032
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 21, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFT
    PMA / PMN Number
    K152227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE CUSTOMER STATED THAT THE EVENT OCCURRED WHEN THEY SWITCHED FROM THE STANDBY REAGENT TO THE IN-USE REAGENT. THE CUSTOMER STATED THAT THEIR QC RECOVERY DATA WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH FOAM OR AIR BUBBLES IN THE USED REAGENT PACK.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CORTISOL II RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 - COBAS E 602 MODULE. FOR SAMPLE 1, THE INITIAL CORTISOL RESULT WAS >63.44 UG/DL. THE SAMPLE WAS REPEATED ON ANOTHER E602 ANALYZER AND THE RESULT WAS 27.51 UG/DL. THE SAMPLE WAS REPEATED AGAIN ON THE INITIAL ANALYZER AGAIN AND THE RESULT WAS 26.94 UG/DL. FOR SAMPLE 2, THE INITIAL CORTISOL RESULT WAS >63.44 UG/DL. THE SAMPLE WAS REPEATED ON ANOTHER E602 ANALYZER AND THE RESULT WAS 22.34 UG/DL. THE SAMPLE WAS REPEATED AGAIN ON THE INITIAL ANALYZER AGAIN AND THE RESULT WAS 21.98 UG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391513 ELECSYS CORTISOL II FLUOROMETRIC, CORTISOL JFT ROCHE DIAGNOSTICS 74466601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown