BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS DHEA-S

    MDR report key: 20668217 · Received November 12, 2024

    Report

    Report Number
    1823260-2024-03284
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 21, 2024
    Report Date
    January 3, 2025
    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 E801 ANALYZER SERIAL NUMBER WAS (B)(6). SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE ACCEPTABLE. SAMPLE MATERIAL WAS RECEIVED FOR INVESTIGATION. FURTHER INVESTIGATION OF THE PATIENT SAMPLE SUGGESTS THE PRESENCE OF AN INTERFERENT AGAINST THE STREPTAVIDIN COMPONENT OF THE REAGENT. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING: "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.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS DHEA-S (DHEA-S) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO THE LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY (LC-MS) METHOD. THE INITIAL RESULT WAS >1000 UG/DL. THE SAMPLE WAS REPEATED "SEVERAL" TIMES AND THE RESULTS REMAINED >1000 UG/DL. THE HIGH RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. DUE TO THE HIGH RESULTS, REPEAT TESTING BY LC-MS WAS REQUESTED. THE RESULT FROM THE LC-MS METHOD WAS 382.54 UG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643853 ELECSYS DHEA-S DEHYDROEPIANDROSTERONE TEST SYSTEM JKC ROCHE DIAGNOSTICS 79099701 04015630940387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown