BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ACTH

    MDR report key: 23905893 · Received December 29, 2025

    Report

    Report Number
    1823260-2025-05351
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    December 9, 2025
    Report Date
    December 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CKG
    UDI-DI
    04015630939893
    PMA / PMN Number
    K060585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE E801 ANALYZER SERIAL NUMBER WAS (B)(6). SAMPLE MATERIAL FROM THE PATIENT WAS RECEIVED FOR INVESTIGATION. THE CUSTOMER'S HIGH ACTH RESULTS WERE REPRODUCED AT THE INVESTIGATION SITE. SAMPLE MATERIAL FROM THE PATIENT WAS SENT TO AN EXTERNAL LABORATORY AND TESTED BY THE SIEMENS METHOD, WHERE THE ACTH WAS ALSO EXTREMELY HIGH (80,163 PG/ML). INTERFERENCE TESTING USING SIZE EXCLUSION CHROMATOGRAPHY (SEC) WAS PERFORMED. NO INTERFERENCE WAS FOUND. PEPTIDE MAPPING ANALYSIS OF THE SAMPLE FRACTIONS SUGGESTS THE HIGH ELECSYS ACTH RESULTS ARE CONSISTENT WITH AN ERRONEOUS DETECTION OF A DIFFERENT PEPTIDE FROM THE HIGHER-LEVEL PROOPIOMELANOCORTIN (POMC) PROTEIN.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS ACTH (ACTH) ON A COBAS E 801 ANALYTICAL UNIT. THE ACTH RESULTS ARE ALLEGEDLY HIGH WITH NO KNOWN CAUSE, AS THE PATIENT IS ASYMPTOMATIC (PREVIOUSLY CUSHING'S DISEASE). THE INITIAL RESULT WAS 118,000 PG/ML. THE SAMPLE WAS REPEATED WITH VARIOUS DILUTIONS: X5: > 2000 PG/ML WITH A DATA FLAG, X10: >2000 PG/ML WITH A DATA FLAG, X20: >2000 PG/ML WITH A DATA FLAG, X40: >2000 PG/ML WITH A DATA FLAG, X75: 118,350 PG/ML, X100: 126,400 PG/ML. ON (B)(6) 2025, A NEW SAMPLE WAS OBTAINED, AND THE RESULT WAS APPROXIMATELY 25,000 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2847947 ELECSYS ACTH ADRENOCORTICOTROPIC HORMONE (ACTH) TEST SYSTEM CKG ROCHE DIAGNOSTICS ASKU 04015630939893

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female DETA| ESCITALOPRAM| ESTRADIOL| FISH OIL| FLUDROCORTIZONE| HYDROCORTISONE| PREDNISONE| PROBIOTICS| PSYLLIUM| SOLU-CORTEF| SOMATROPIN INJECTION| VITAMIN C