BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CORTISOL II

    MDR report key: 8154532 · Received December 12, 2018

    Report

    Report Number
    1823260-2018-04808
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 6, 2018
    Report Date
    January 3, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFT
    PMA / PMN Number
    K152227
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE WAS SENT FOR INVESTIGATION. UPON INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST A COMPONENT OF THE REAGENT WAS CONFIRMED. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING: IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. NO PRODUCT PROBLEM WAS FOUND.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A QUESTIONABLE ELECSYS CORTISOL II RESULT FOR 1 PATIENT SAMPLE TESTED ON A COBAS 8000 E 801 MODULE COMPARED TO THE RESULT FROM A SIEMENS CENTAUR SYSTEM. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E801 USED AT THE CUSTOMER'S SITE SERIAL NUMBER WAS (B)(4). THE COBAS E801 USED AT THE INVESTIGATION SITE SERIAL NUMBER WAS (B)(4). THE CORTISOL REAGENT USED ON THIS INSTRUMENT WAS LOT 336133 WITH AN EXPIRATION DATE 19-NOV-2019. THE INVESTIGATION IS CURRENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997414 ELECSYS CORTISOL II FLUOROMETRIC, CORTISOL JFT ROCHE DIAGNOSTICS NA 336133

    Patients

    Seq Age Sex Outcome Treatment
    1