BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS DHEA-S

    MDR report key: 19289035 · Received May 10, 2024

    Report

    Report Number
    1823260-2024-01414
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 17, 2024
    Report Date
    June 6, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKC
    UDI-DI
    04015630940387
    PMA / PMN Number
    K003174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS SUBMITTED FOR INVESTIGATION. UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENCE AGAINST THE STREPTAVIDIN COMPONENT OF THE REAGENT WAS CONFIRMED. PRODUCT LABELING STATES: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE E801 ANALYZER SERIAL NUMBER WAS (B)(4). THE COMPETITOR METHOD WAS ABBOTT. THE SAMPLE WAS REQUESTED FOR INVESTIGATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS DHEA-S (DHEA-S) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. THE INITIAL RESULT FROM THE E801 ANALYZER WAS > 1000 UG/DL. THE SAMPLE WAS SENT TO TWO EXTERNAL LABORATORIES USING THE SAME COMPETITOR METHOD AND THE RESULTS WERE APPROXIMATELY 230 UG/DL. THE REPEAT RESULT ON THE E801 ANALYZER WAS > 1000 UG/DL. ON 25-APR-2024 THE SAMPLE WAS REPEATED ON THE E801 ANALYZER AND THE RESULT WAS > 1000 UG/DL WITH A DATA FLAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519202 ELECSYS DHEA-S DEHYDROEPIANDROSTERONE TEST SYSTEM JKC ROCHE DIAGNOSTICS 75160903 04015630940387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown