BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CORTISOL TEST SYSTEM

    MDR report key: 12286561 · Received August 6, 2021

    Report

    Report Number
    1823260-2021-02295
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 19, 2021
    Report Date
    February 18, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    K070788
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. THE RESULTS OBTAINED BY THE CUSTOMER COULD BE REPRODUCED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATIONS OF THE PROVIDED SAMPLE DETERMINED THAT IT DOES NOT CONTAIN AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE CORTISOL ASSAY. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    CALIBRATION DATA WAS REVIEWED AND SIGNALS WERE WITHIN EXPECTATIONS. QUALITY CONTROLS WERE WITHIN RANGE ON THE DAY OF THE EVENT. UPON REVIEW OF THE ALARM TRACE, NO RELEVANT ALARMS WERE OBSERVED FROM (B)(6) 2021 TO (B)(6) 2021. DURING INVESTIGATIONS, THE SAMPLE WAS TESTED WITH A LC-MS/MS METHOD AND THE RESULTS AGREED WITH THE ELECSYS CORTISOL RESULT. THE ELECSYS CORTISOL RESULT IS CONSIDERED CORRECT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER NAME AND ADDRESS: (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS CORTISOL TEST SYSTEM ON A COBAS 8000 E 602 MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CORTISOL VALUE OF 48.70 UG/DL ON THE E 602 ANALYZER. THE SAMPLE WAS REPEATED IN A SECOND LABORATORY USING THE SIEMENS CLIA METHOD, RESULTING IN A VALUE OF 22.21 UG/L. THE 22.21 UG/DL VALUE WAS BELIEVED TO BE CORRECT AND WAS RELEASED TO THE PATIENT. THE SAMPLE WAS REPEATED ON THE E 602 ANALYZER ON (B)(6) 2021, RESULTING IN A CORTISOL VALUE OF 45.96 UG/DL. THE SAMPLE WAS REPEATED AT THE SECOND LABORATORY USING THE SIEMENS CLIA METHOD ON (B)(6) 2021, RESULTING IN A CORTISOL VALUE OF 24.55 UG/DL. THE SERIAL NUMBER OF THE E 602 ANALYZER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183544 ELECSYS CORTISOL TEST SYSTEM ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS NA 500087

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female