BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS DHEA-S

    MDR report key: 22131214 · Received June 3, 2025

    Report

    Report Number
    1823260-2025-01701
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 12, 2025
    Report Date
    September 8, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKC
    UDI-DI
    04015630917372
    PMA / PMN Number
    K003174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS E 602 MODULE (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE PATIENT STOPPED TAKING THE MACA (LEPIDIUM MEYENII) MEDICATION FOR A MONTH. THE ELECSYS DHEA-S RESULT WAS STILL >1000 UG/DL. THE CALIBRATION AND QCS WERE ACCEPTABLE. THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION AND WAS TESTED FOR INTERFERENTS. THE INVESTIGATION DETECTED THE PRESENCE OF AN INTERFERENT IN THE PATIENT SAMPLE, WHICH CAUSED THE EVENT. PRODUCT LABELING STATES, "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. 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.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS DHEA-S RESULT FROM THE COBAS E 602 MODULE. THE INITIAL RESULT WAS > 1000 G/DL, AND THE REPEAT RESULT WAS > 1000 G/DL. THE SAMPLE WAS REPEATED ON A NON-ROCHE DEVICE WITH A RESULT OF 301.07 G/DL. THE SAMPLE WAS REPEATED ON ANOTHER NON-ROCHE DEVICE WITH A RESULT OF 212.502 G/DL. THE INITIAL RESULT WAS QUESTIONED BECAUSE IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS AND WAS NOT RELEASED OUTSIDE OF THE LABORATORY. THE RESULTS OF 301.07 G/DL AND 212.502 G/DL ARE DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065432 ELECSYS DHEA-S DEHYDROEPIANDROSTERONE (FREE AND SULFATE) TEST SYSTEM JKC ROCHE DIAGNOSTICS 79098700 04015630917372

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male MACA - LEPIDIUM MEYENII.