BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS DHEA-S

    MDR report key: 19793989 · Received July 22, 2024

    Report

    Report Number
    1823260-2024-02106
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 27, 2024
    Report Date
    November 25, 2024
    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 CUSTOMER'S CALIBRATION AND QC RESULTS WERE WITHIN ACCEPTABLE RANGES. TWO PATIENT SAMPLES WERE RECEIVED FOR INVESTIGATION. THE TWO PATIENT SAMPLES WERE TESTED FOR THE PRESENCE OF AN INTERFERENT AND NO INTERFERENCE WAS DETECTED. THE INVESTIGATION CONFIRMED THAT THE CUSTOMER'S RESULTS WERE CORRECT. THE INVESTIGATION EXCLUDED A GENERAL REAGENT ISSUE. THE INVESTIGATION DETERMINED THAT THE COMPETITOR AND LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY (LC-MS) METHOD RESULTS WERE CONSISTENT WITH THE ELECSYS DHEA-S ASSAY RESULTS AND THE RESULTS WERE CONFIRMED WITH PATIENT 1'S DIAGNOSES. PRODUCT LABELING STATES "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. MEDWATCH FIELD B7 OTHER RELEVANT HISTORY WAS UPDATED.

    Additional Manufacturer Narrative · 0

    ON 19-AUG-2024, THE CUSTOMER PROVIDED ADDITIONAL DATA REGARDING THE EVENT: THE MASS SPECTROMETER RESULT FOR DHEA WAS 3.67 ¿G/DL. IT WAS NOT SPECIFIED WHETHER THE RESULT WAS FOR PATIENT 01 OR PATIENT 02. THE SAMPLES WERE REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE E801 ANALYZER SERIAL NUMBER WAS (B)(6). THE CUSTOMER REPORTS THAT QCS WERE ON TARGET. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS DHEA-S (DHEA-S) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. PATIENT 01: THE INITIAL RESULT FROM THE E801 ANALYZER WAS > 1000 G/DL. THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING THE BECKMAN COULTER DXI 800 AND THE RESULT WAS 710 G/DL. PATIENT 02: THE INITIAL RESULT FROM THE E801 ANALYZER WAS > 1000 G/DL. THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING THE BECKMAN COULTER DXI 800 AND THE RESULT WAS 947.1 G/DL. THE SAMPLE WAS RUN BY LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY (LC-MS) METHOD AND THE DHEA-S RESULT WAS 517.97 NMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003602 ELECSYS DHEA-S DEHYDROEPIANDROSTERONE TEST SYSTEM JKC ROCHE DIAGNOSTICS 75160903 04015630940387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown