BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTISOL

    MDR report key: 5850920 · Received August 5, 2016

    Report

    Report Number
    1823260-2016-01115
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    July 11, 2016
    Report Date
    August 5, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    K070788
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED FOR CORTISOL AND CORTISOL II. THE ERRONEOUS RESULTS WERE BETWEEN THE CORTISOL TESTS RUN ON AN E601 ANALYZER AND CORTISOL II TESTS RUN ON AN E602 ANALYZER. THE CORTISOL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY WERE QUESTIONED BY THE PHYSICIAN SINCE THEY DIDN'T MATCH THE PATIENT'S CLINICAL SYMPTOMS. THIS MEDWATCH WILL COVER CORTISOL. REFER TO MEDWATCH WITH (B)(6) FOR INFORMATION ON THE CORTISOL II ERRONEOUS RESULTS. THE INITIAL CORTISOL RESULT FROM THE E601 ANALYZER WAS 384.1 NMOL/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON (B)(6) 2016 AND THE RESULT WAS 385.7 NMOL/L. A NEW SAMPLE WAS OBTAINED AND THE CORTISOL RESULT FROM THE E601 ANALYZER WAS 258.4 NMOL/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON (B)(6) 2016 AND THE RESULT WAS 272.1 NMOL/L. BOTH SAMPLES WERE ALSO TESTED FOR CORTISOL II ON THE E602 ANALYZER. THE INITIAL SAMPLE WAS REPEATED TWICE AND THE CORTISOL II RESULTS WERE 1750 NMOL/L WITH A DATA FLAG AND 5658 NMOL/L. THE 2ND SAMPLE WAS REPEATED TWICE AND THE CORTISOL II RESULTS WERE 1750 NMOL/L WITH A DATA FLAG AND 2837 NMOL/L. THE BIOCHEMIST IS NOW QUESTIONING THE DIFFERENCE BETWEEN THE RESULTS FROM CORTISOL AND CORTISOL II AND WONDERING IF THERE COULD BE AN INTERFERENCE. OTHER PATIENTS WERE TESTED AND THE SAME BEHAVIOR WAS NOT OBSERVED. NO ADVERSE EVENT OCCURRED. THE E601 ANALYZER SERIAL NUMBER WAS NOT PROVIDED. THE E602 ANALYZER SERIAL NUMBER WAS NOT PROVIDED. A GENERAL REAGENT ISSUE IS NOT SUSPECTED BASED ON THE QUALITY CONTROL DATA PROVIDED. THE SAMPLE AND REAGENT HANDLING AT THE CUSTOMER SITE SEEMS TO BE IN ACCORDANCE WITH SPECIFICATIONS. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502682 CORTISOL ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS NA 18538000

    Patients

    Seq Age Sex Outcome Treatment
    1