BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTISOL

    MDR report key: 5535833 · Received March 30, 2016

    Report

    Report Number
    1823260-2016-00381
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    February 20, 2016
    Report Date
    March 30, 2016
    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 OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FOR 1 PATIENT TESTED FOR CORTISOL. THE PATIENT TYPICALLY HAD LOW CORTISOL RESULTS WITH SERUM SAMPLES BUT ON (B)(6) 2016 A URINE SAMPLE FROM THE PATIENT PRODUCED A HIGH CORTISOL RESULT. THE CUSTOMER SENT THE PATIENT SAMPLE IN FOR FURTHER INVESTIGATION. DURING THE INVESTIGATION ERRONEOUS CORTISOL RESULTS WERE IDENTIFIED BETWEEN THE E411 ANALYZER USED AT THE INVESTIGATION SITE AND A CENTAUR ANALYZER. THE RESULTS FROM THE INVESTIGATION WILL BE PROVIDED TO THE CUSTOMER. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENT OCCURRED. THE E411 ANALYZER USED AT THE INVESTIGATION SITE WAS HOL-3252. THE CORTISOL REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 122033 WITH AN EXPIRATION DATE OF 04/2017. THE CORTISOL II ASSAY IS NOT SOLD IN THE UNITED STATES. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. A GENERAL REAGENT ISSUE HAS NOT BEEN IDENTIFIED BASED ON THE QUALITY CONTROL DATA. THE RESULTS FROM THE E411 ANALYZER AND THE CENTAUR ANALYZER SHOW THE SAME CLINICAL PICTURE WHICH SEEMS TO MATCH THE CLINICAL PICTURE OF THE PATIENT. IT IS NOT KNOWN WHY THE URINE SAMPLE FROM (B)(6) 2016 WAS ELEVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190352 CORTISOL ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS NA 18538006

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR