BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS DHEA-S

    MDR report key: 23631125 · Received November 24, 2025

    Report

    Report Number
    1823260-2025-04799
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 1, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKC
    UDI-DI
    04015630940387
    PMA / PMN Number
    K003174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) FOUND A KINKED PROCELL LINE. THE FSE REPLACED AND RESEATED THE PROCELL LINE. QC WAS ACCEPTABLE; HOWEVER, THE INSTRUMENT CHECK FAILED. PREVENTIVE MAINTENANCE WAS PERFORMED. MECHANICAL CHECKS PASSED. THE INSTRUMENT WAS OPERATING WITHIN SPECIFICATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE QC WAS IN RANGE PRIOR TO THE EVENT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS DHEA-S ASSAY ON A COBAS E 801 ANALYTICAL UNIT. INITIAL RESULT: 630 UG/DL. THE QC WENT OUT OF RANGE, PROMPTING THE REPEAT OF THE SAMPLES. REPEAT RESULT: 417 UG/DL (IT IS UNCLEAR IF THIS RESULT WAS FROM THE SAME OR A DIFFERENT E 801). THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2749863 ELECSYS DHEA-S DEHYDROEPIANDROSTERONE TEST SYSTEM JKC ROCHE DIAGNOSTICS DHEA-S 85726701 04015630940387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown