BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTISOL

    MDR report key: 2713544 · Received August 24, 2012

    Report

    Report Number
    1823260-2012-04305
    Event Type
    Malfunction
    Date Received
    August 24, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 24, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    K070788
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER DISCOVERED QUESTIONABLE CORTISOL RESULTS FOR ONE PATIENT WHEN THE RESULTS FROM OTHER ANALYZERS WERE COMPARED. THE RESULT RECEIVED FROM A COBAS E411 ANALYZER AND REPEATED ON A COBAS E601 WAS 60 NMOL/L WHICH WAS BELOW THE REFERENCE RANGE. THEY REPEATED THE MEASUREMENTS AGAIN AND THE RESULT WAS 66 NMOL/L. THE SAMPLE WAS FROZEN AND LATER MEASURED ON AXSYM AND THE RESULT WAS WITHIN THE REFERENCE RANGE. NO SPECIFIC DATA WAS PROVIDED. THE SAME SAMPLE WAS THEN MEASURED IN ANOTHER LABORATORY ON AN ANALYTICAL E MODULE ANALYZER AND THE RESULT WAS 51 NMOL/L. THE RESULT FROM AN ARCHITECT ANALYZER WAS 234.5 NMOL/L. ANOTHER SAMPLE FROM THIS PATIENT WAS ANALYZED BY RIA METHOD AND THE RESULT WAS WITHIN THE REFERENCE RANGE. NO SPECIFIC DATA WAS PROVIDED. NO INFORMATION WAS PROVIDED TO DETERMINE IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY OR IF THE PATIENT WAS ADVERSELY AFFECTED. THE SERIAL NUMBERS OF THE INVOLVED ANALYZERS WERE NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. AS THE SAMPLE WAS MEASURED IN DIFFERENT LABS WITH DIFFERENT ANALYZERS, A GENERAL REAGENT OR ANALYZER ISSUE WAS NOT SUSPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR