BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CORTISOL

    MDR report key: 19222320 · Received May 1, 2024

    Report

    Report Number
    1823260-2024-01328
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 5, 2024
    Report Date
    May 29, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    K070788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MATERIAL NUMBER FOR THE CORTISOL ASSAY WAS PROVIDED. THE PATIENT SAMPLES WERE SENT TO AN EXTERNAL LABORATORY FOR THE DETERMINATION OF URINARY-FREE CORTISOL BY LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY (LC-MS/MS). THE RESULTS WERE CONSISTENT WITH THE CUSTOMER'S RESULTS USING THE CORTISOL III REAGENT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED TO INVESTIGATE ADDITIONAL CAUSAL FACTORS FOR THE HIGH ELECSYS CORTISOL VALUES (E.G. SAMPLE HANDLING/MANUAL EXTRACTION, POTENTIAL CROSS-REACTANTS, ETC). RESULTS FOR ELECSYS CORTISOL AND ELECSYS CORTISOL III FOR URINE TESTING ARE NOT DIRECTLY COMPARABLE AND HIGHER VALUES WITH ELECSYS CORTISOL COMPARED TO ELECSYS CORTISOL III ARE EXPECTED. THIS IS DUE TO THE USE OF DIFFERENT ANTIBODIES WITH DIFFERENT SPECIFICITIES, ELIMINATION OF THE EXTRACTION PROTOCOL, AND STANDARDIZATION DIRECTLY AGAINST ISOTOPE DILUTION-LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY (ID-LC-MS/MS). INSTRUCTIONS FOR PROPER MANUAL EXTRACTION PROCEDURES AND POTENTIAL CROSS REACTANTS FOR THE ELECSYS CORTISOL ASSAY ARE PROVIDED IN PRODUCT LABELING. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED THE RESULTS BETWEEN ELECSYS CORTISOL (CORTISOL) AND CORTISOL III FOR "SEVERAL" PATIENT URINE SAMPLES TESTED ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE CUSTOMER ALLEGES THAT THE CLINICAL INTERPRETATION OF THE PATIENT SAMPLES DIFFERS BETWEEN CORTISOL AND CORTISOL III. NOTE: THE CORTISOL III ASSAY IS NOT APPROVED FOR USE IN THE UNITED STATES NOR IS IT LIKE OR SIMILAR TO THE CORTISOL ASSAY AVAILABLE IN THE US. THE CUSTOMER PROVIDED EXAMPLES OF RESULTS FOR 2 PATIENT SAMPLES. PATIENT 1 (24-HOUR URINE COLLECTION WITH A DIURESIS OF 6L): CORTISOL RESULTS AFTER EXTRACTION WITH DICHLOROMETHANE WERE 8.85 UG/DL, 10.900 UG/DL, AND 10.12 UG/DL. THE CORTISOL III RESULT AFTER EXTRACTION WITH DICHLOROMETHANE WAS 0.272 UG/DL. THE CORTISOL RESULT WITHOUT EXTRACTION WAS 37.57 UG/DL. THE SAMPLE WAS RUN 4 TIMES WITHOUT EXTRACTION AND WAS DILUTED 1:3 AND 1:10 AND THE CORTISOL III RESULTS WERE ALL 0.272 UG/DL WITH A DATA FLAG. PATIENT 2 (24-HOUR URINE COLLECTION WITH A DIURESIS OF 2.7L): THE CORTISOL RESULT AFTER EXTRACTION WITH DICHLOROMETHANE WAS 35.88 UG/DL. WITH A DIURESIS OF 2.7L, THE RESULT WAS 968.76 G/24 H. THE REFERENCE RANGE IS 36-137 G/24 H. THIS WAS DEEMED A VERY HIGH RESULT. THE CORTISOL III RESULT WITHOUT EXTRACTION WAS 1.87 UG/DL. WITH A DIURESIS OF 2.7L, THE RESULT WAS 50.49 G/24 H. THE REFERENCE RANGE IS 11.5-102 G/24 H. THIS WAS DEEMED A NORMAL RESULT. THE CUSTOMER REPLACED THE MEASURING CELL ON THE E411 ANALYZER AS IT WAS DUE FOR REPLACEMENT. AFTER REPLACING THE MEASURING CELL, THE CUSTOMER REPEATED THE PATIENT SAMPLES WITH EACH ASSAY. PATIENT 1: THE CORTISOL RESULT WAS 38.24 UG/DL. THE CORTISOL III RESULT WAS 1.71 UG/DL. PATIENT 2: THE CORTISOL RESULT WAS 1.71 UG/DL. THE CORTISOL III RESULT WAS 46.17 UG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147231 ELECSYS CORTISOL ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male