BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CORTISOL II

    MDR report key: 10384723 · Received August 10, 2020

    Report

    Report Number
    1823260-2020-01937
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 10, 2020
    Report Date
    August 10, 2020
    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 · 1

    THIS EVENT OCCURRED IN (B)(6). THE PATIENT'S SAMPLE WAS REQUESTED FOR INVESTIGATION, BUT THE PATIENT'S SAMPLE WAS NOT AVAILABLE. THE CUSTOMER'S QC WAS ACCEPTABLE. A GENERAL REAGENT ISSUE CAN BE EXCLUDED. PER PRODUCT LABELING, "FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CORTISOL II RESULTS FOR ONE PATIENT TESTED ON A COBAS 6000 E 601 MODULE. ON (B)(6) 2020, THE PATIENT'S INITIAL CORTISOL RESULT WAS GREATER THAN 63.4 UG/DL. THE CUSTOMER PERFORMED 1:20 AND 1:50 DILUTION TESTING ON THE SAMPLE FOR FURTHER CONFIRMATION. THE PATIENT'S 1:20 DILUTION CORTISOL RESULT WAS 1196 UG/DL, AND THE 1:50 DILUTION CORTISOL RESULT WAS 1177 UG/DL. THE RESULT OF 1196 UG/DL WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2020, THE PATIENT HAD A NEW SAMPLE COLLECTED FOR TESTING. THE CUSTOMER PERFORMED A 1:20 DILUTION ON THE PATIENT'S SAMPLE TO REPRODUCE THE RESULTS FROM (B)(6) 2020. THE PATIENT'S CORTISOL RESULT WAS 25 UG/DL. THIS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE E 601 SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849181 ELECSYS CORTISOL II FLUOROMETRIC, CORTISOL JFT ROCHE DIAGNOSTICS CORTISOL G2 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO