BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS DHEA-S

    MDR report key: 22435553 · Received July 8, 2025

    Report

    Report Number
    1823260-2025-02077
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    February 28, 2025
    Report Date
    March 24, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKC
    UDI-DI
    04015630940387
    PMA / PMN Number
    K003174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    FOUR PATIENT SAMPLES WERE RECEIVED FOR INVESTIGATION. IT IS NOT CLEAR WHICH PATIENTS THESE SAMPLES CORRESPOND TO. THE INVESTIGATION REPRODUCED THE RESULTS OF >1000 ¿G/DL, WITH DATA FLAGS FOR ALL FOUR SAMPLES RECEIVED. THE IONIFY (LC-MS/MS) ANALYSIS CONFIRMED TRULY SUPRAPHYSIOLOGICAL DHEA-S LEVELS BETWEEN 837.4 AND 891.4 ¿G/DL FOR THREE SAMPLES. COMPARISON TESTING SHOWED THAT WHILE THE ELECSYS RESULTS WERE HIGH (>1000 ¿G/DL), THE BECKMAN RESULTS (~300-400 ¿G/DL) WERE SIGNIFICANTLY LOWER COMPARED TO THE MASS SPECTROMETRY RESULTS (~850 ¿G/DL). THE ELECSYS RESULTS ARE CLOSER TO THE IONIFY (LC-MS/MS) RESULTS COMPARED TO BECKMAN. THE IONIFY RESULTS CONFIRM ACTUAL SUPRAPHYSIOLOGIC PATIENT CONCENTRATIONS (>800 ¿G/DL). THIS SUGGESTS AN UNDERLYING ADRENAL (HORMONAL) PATHOLOGY IS PRESENT, RATHER THAN TECHNICAL ISSUES. PER 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.

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELD B3 DATE OF EVENT HAS BEEN UPDATED. MEDWATCH SECTION D10: CONCOMITANT MEDICAL PRODUCTS UPDATED. FULL PRESCRIPTION INFORMATION: NORGESTIMATE-ETHINYL ESTRADIOL (ORTHO-CYCLEN/SPRINTEC) 0.25-0.035 MG ORAL TAB. THE PATIENT FOR DATA REPORTED IN INITIAL MEDWATCH MFG REPORT NUMBER 1823260-2025-02077 IS DOCUMENTED AS PATIENT 4 IN FOLLOW-UP MEDWATCH MFG REPORT NUMBER 1823260-2025-02077-01. MOVING FORWARD, THIS PATIENT WILL BE REFERRED TO AS PATIENT 4. PATIENT 4 HAS PCOS. THE CUSTOMER PROVIDED DATA FOR TWO ADDITIONAL PATIENT SAMPLES WITH DISCREPANT DHEA-S RESULTS (PATIENTS 6 AND 7). PATIENT 6'S INITIAL RESULT ON (B)(6) 2025 WAS >1000 MCG/DL, AND THE REPEAT RESULT ON THE E 402 ANALYZER ON (B)(6) 2025 WAS 911 MCG/DL. PATIENT 7'S INITIAL RESULT ON (B)(6) 2025 WAS >1000 MCG/DL, AND THE REPEAT RESULT ON THE E 402 ANALYZER ON (B)(6) 2025 WAS 873 MCG/DL. PATIENT 6 IS A 15-YEAR-OLD FEMALE WITH CUSHING'S DISEASE. PATIENT 7 IS A 66-YEAR-OLD MALE WITH ADRENAL CORTICAL CARCINOMA. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FULL PRESCRIPTION NAME PROVIDED IN CONCOMITANT MEDICAL PRODUCT IS: NORGESTIMATE-ETHINYL ESTRADIOL (ORTHO-CYCLEN/SPRINTEC). SEE THE ATTACHMENT "RESULTS - CN-1059433.XLSX" FOR THE ADDITIONAL RESULTS AND INFORMATION REPORTED. IT WAS ALSO PROVIDED THAT THE CUSTOMER'S QC WAS PASSING AT THE TIME OF THE EVENTS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS DHEA-S RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS > 1000 MCG/DL, AND THE REPEAT RESULT FROM AN E 402 ANALYZER WAS 271 MCG/DL. THE INITIAL RESULT WAS QUESTIONED BY THE PROVIDER AND REPEATED. THERE WAS NO CORRECTED RESULT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387526 ELECSYS DHEA-S DEHYDROEPIANDROSTERONE TEST SYSTEM JKC ROCHE DIAGNOSTICS 815067 04015630940387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NORGESTIMATE-ETHINYL ESTRADIOL (ORTHO-CYCLEN) -PT4