BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTISOL

    MDR report key: 3773403 · Received April 25, 2014

    Report

    Report Number
    1823260-2014-03075
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 1, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    K070788
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED ONE PATIENT SAMPLE FOR INVESTIGATION. THE SAMPLE WAS TESTED ON A COBAS E602 USING CORTISOL RETENTION REAGENT LOT NUMBER 174778. THE CUSTOMER'S SAMPLE RESULT WAS REPRODUCED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE PATIENT SAMPLE INDICATED AN INTERFERENCE WAS PRESENT IN THE PATIENT SAMPLE. INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES CAN OCCUR. THE LOW CORTISOL VALUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THIS INTERFERENCE IS DOCUMENTED IN PRODUCT LABELING.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE CORTISOL RESULTS FOR ONE PATIENT ON THEIR COBAS 8000 E602 MODULE, SERIAL NUMBER (B)(4). THE PATIENT'S INITIAL CORTISOL RESULT WAS 2.90 UG/L. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED IN THE ROCHE METHOD. THE REPEAT RESULT WAS 4 NG/ML. THE SAMPLE WAS THEN SENT TO ANOTHER LABORATORY AND TESTED WITH A BECKMAN-COULTER METHOD AND THE RESULT WAS 154 NG/ML. THE CUSTOMER STATED THE ROCHE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250983 CORTISOL ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS NA 174778

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR TRAMSULOSINE| ARTORVASTATINE| REBEPRAZOLE| LERCANIDIPINE