BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTISOL

    MDR report key: 3237666 · Received July 19, 2013

    Report

    Report Number
    1823260-2013-04387
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    July 2, 2013
    Report Date
    October 3, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    K070788
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6) NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLE WAS RETURNED FOR INVESTIGATION. AN INTERFERENCE TO STREPTAVIDIN WAS IDENTIFIED IN THE SAMPLE. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE CORTISOL AND ACTH RESULTS ON THEIR E-MODULE FOR ONE PATIENT. THE CUSTOMER PROVIDED DATA FOR ONE DISCREPANT CORTISOL RESULT. THE PATIENT'S INITIAL CORTISOL RESULT WAS 24.3 UG/DL AND IT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2013, THE SAMPLE WAS REPEATED AND THE RESULT WAS 27.9 UG/DL. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING. THE EXACT DATE OF THE TEST WAS REQUESTED BUT NOT PROVIDED. IT WAS ASSUMED BY THE CUSTOMER THAT THE SECOND LABORATORY TESTED THE SAMPLE USING A CENTAUR ANALYZER. THIS REPEAT RESULT WAS 9.9 UG/DL. THERE HAD BEEN NO REPORTS OF ANY ADVERSE EVENTS. THE CORTISOL REAGENT LOT NUMBER WAS 171646 AND THE EXPIRATION DATE WAS 06/29/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337809 CORTISOL ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS NA 171646

    Patients

    Seq Age Sex Outcome Treatment
    1