BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS DHEA-S

    MDR report key: 23865711 · Received December 22, 2025

    Report

    Report Number
    1823260-2025-05277
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 24, 2025
    Report Date
    January 30, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKC
    UDI-DI
    04015630940387
    PMA / PMN Number
    K003174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE ACCEPTABLE. THE ALARM TRACE WAS REVIEWED, AND NO ALARMS RELATED TO THE EVENT WERE IDENTIFIED. THE SAMPLE WAS REQUESTED FOR INVESTIGATION, BUT COULD NOT BE PROVIDED. THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL PATIENT INFORMATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE E402 ANALYZER SERIAL NUMBER WAS (B)(6).

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS DHEA-S (DHEA-S) ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS > 1000 G/DL WITH A DATA FLAG. THE REPEAT USING A 1:5 DILUTION WAS 113 G/DL; THE CALCULATED RESULT WAS 565 G/DL. THE MEASURING RANGE OF THE ASSAY IS 0.2 ¿ 1000 G/DL. THE CUSTOMER QUESTIONS WHY THE SAMPLE WOULD REQUIRE DILUTION, AS THE RESULT OF 565 G/DL WAS WITHIN THE MEASURING RANGE OF THE ASSAY. THE CUSTOMER SUSPECTS AN INTERFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84404 ELECSYS DHEA-S DEHYDROEPIANDROSTERONE TEST SYSTEM JKC ROCHE DIAGNOSTICS DHEA-S 857267 04015630940387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown