BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CORTISOL

    MDR report key: 17905184 · Received October 10, 2023

    Report

    Report Number
    1823260-2023-03242
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    September 14, 2023
    Report Date
    October 24, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    K070788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEDICAL DEVICE PROBLEM CODE WAS UPDATED. THE FIELD SERVICE ENGINEER (FSE) REPLACED PINCH VALVE TUBES AND ADJUSTED THE SAMPLE/REAGENT PROBE LIQUID LEVEL DETECTION (LLD) VOLTAGE AND THE BEAD MIXER MECHANISM. IT WAS FOUND THAT THE CUSTOMER USED 13 MM SAMPLE TUBES WITH NO RACK ADAPTERS AND LIQUID FLOW CLEANING (LFC) WAS OVERDUE. THE INVESTIGATION DETERMINED THE CAUSE OF THE EVENT WAS THE MISADJUSTED SAMPLE/REAGENT PROBE LLD VOLTAGE. THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE E411 ANALYZER SERIAL NUMBER WAS (B)(6).

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CORTISOL (CORTISOL) ON A COBAS E 411 ANALYZER (RACK SYSTEM) COMPARED TO A COMPETITOR METHOD. THE INITIAL RESULT FROM THE E411 ANALYZER WAS 0.671 UG/DL. THE REPEAT RESULT FROM THE COMPETITOR ANALYZER WAS 10.73 UG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296042 ELECSYS CORTISOL ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS 71165000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown