BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTISOL

    MDR report key: 2132643 · Received June 17, 2011

    Report

    Report Number
    1823260-2011-03316
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    K070788
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER ASSAYS RELATED TO THIS EVENT ARE REPORTED IN MEDWATCH REPORTS PATIENT IDENTIFIERS: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY WERE RECEIVING QUESTIONABLE RESULTS FOR CORTISOL ON THEIR MODULAR ANALYTICS E-MODULE (SERIAL NUMBER (B)(4)). THE CUSTOMER PROVIDED DATA FOR FOUR SAMPLES WITH DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. REPEAT TESTING WAS PERFORMED ON THE SAME E-MODULE AND ISSUED AS A CORRECTED REPORT. THE FIRST PATIENT'S INITIAL CORTISOL RESULT WAS 57.92 UG/DL. THE REPEAT RESULT WAS 11.50 UG/DL. THE SECOND PATIENT'S INITIAL CORTISOL RESULT WAS 4.26 UG/DL. THE REPEAT RESULT WAS 15.38 UG/DL. THE THIRD PATIENT'S INITIAL CORTISOL RESULT WAS 63.44 UG/DL ACCOMPANIED BY A DATA FLAG. THE ANALYZER AUTOMATICALLY REPEATED THE SAMPLE AND THE RESULT WAS 117.3 UG/DL. THE SECOND REPEAT RESULT WAS 15.69 UG/DL. THE FOURTH PATIENT'S INITIAL RESULT WAS 56.86 UG/DL. THE REPEAT RESULT WAS 11.83 UG/DL. THE CUSTOMER WAS NOT AWARE OF ANY ADVERSE AFFECTS TO THE PATIENTS AS A RESULT OF THIS EVENT. THE CUSTOMER REFUSED A SERVICE VISIT. THE CUSTOMER RESOLVED THE ISSUE BY TROUBLESHOOTING THE ANALYZER. THEY PERFORMED LIQUID FLOW CLEANING THREE TIMES AND MEASURING CELL PREPARATION TWENTY TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTISOL ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS NA 15879802

    Patients

    Seq Age Sex Outcome Treatment
    1