BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS DHEA-S

    MDR report key: 22505971 · Received July 15, 2025

    Report

    Report Number
    1823260-2025-02140
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    June 24, 2025
    Report Date
    September 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKC
    UDI-DI
    04015630940387
    PMA / PMN Number
    K003174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE E801 MODULE SERIAL NUMBER WAS (B)(6). SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY (LC-MS) RESULT WAS BELIEVED TO BE CORRECT.

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE ACCEPTABLE. ONE SAMPLE SHORT ALARM WAS OBSERVED WITHIN THE ALARM TRACE DATA ON (B)(6) 2025. NO INSTRUMENT MAINTENANCE ISSUES WERE IDENTIFIED. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION. THE CUSTOMER'S DHEA-S RESULTS WERE REPRODUCED. UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST THE STREPTAVIDIN COMPONENT OF THE REAGENT WAS CONFIRMED. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING: "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

    THE INITIAL REPORTER QUESTIONED HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS DHEA-S (DHEA-S) ON A COBAS 8000 E 801 MODULE. THE RESULT FROM THE E801 MODULE WAS > 1000 UG/DL. THE SAMPLE WAS REPEATED "SEVERAL" TIMES AND THE RESULTS WERE REPRODUCED. THE SAMPLE WAS TESTED BY LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY (LC-MS) AND THE RESULT WAS 93.27 UG/DL. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE ROCHE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573268 ELECSYS DHEA-S DEHYDROEPIANDROSTERONE TEST SYSTEM JKC ROCHE DIAGNOSTICS 85726701 04015630940387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown