BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS DHEA-S

    MDR report key: 21772689 · Received April 4, 2025

    Report

    Report Number
    1823260-2025-01007
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 7, 2025
    Report Date
    May 8, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKC
    UDI-DI
    04015630940387
    PMA / PMN Number
    K003174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QC WAS IN RANGE PRIOR TO THE EVENT. THERE WEREN'T ANY RELEVANT INSTRUMENT ALARMS OR SAMPLE QUALITY ALARMS ON THE DAY OF THE EVENT THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    THE COBAS E 402 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). 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 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 407.0 UG/DL, AND THE REPEAT RESULT WAS 221 UG/DL. THE QUESTIONABLE RESULT WAS REPEATED BECAUSE THE CUSTOMER NOTICED THAT IT WAS VERY HIGH FOR THE PATIENT'S AGE, AND IT WAS NOT RELEASED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632424 ELECSYS DHEA-S DEHYDROEPIANDROSTERONE TEST SYSTEM JKC ROCHE DIAGNOSTICS 790997 04015630940387

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female