BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS DHEA-S

    MDR report key: 11679637 · Received April 16, 2021

    Report

    Report Number
    1823260-2021-01161
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 18, 2021
    Report Date
    May 26, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKC
    PMA / PMN Number
    K003174
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALIBRATION AND QC WERE ACCEPTABLE. FURTHER INVESTIGATIONS WERE PERFORMED ON THE PATIENT SAMPLE. A STREPTAVIDIN INTERFERING FACTOR WAS CONFIRMED WITHIN THE SAMPLE LEADING TO FALSE-HIGH RESULTS FOR ELECSYS DHEA-S. 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 PRODUCT MEETS SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(6) . UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS DHEA-S AND ELECSYS FT3 III RESULTS FOR ONE PATIENT WITH THE COBAS E 801 MODULE SERIAL NUMBER (B)(4) COMPARED TO TWO DIFFERENT COMPETITORS' ANALYZERS. THIS MEDWATCH WILL COVER DHEA-S. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS. THE DHEA-S RESULT FROM THE E801 WAS 4.42 UG/ML. THE RESULT FROM THE SIEMENS ANALYZER WAS 1.66 UG/ML. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580271 ELECSYS DHEA-S DEHYDROEPIANDROSTERONE TEST SYSTEM JKC ROCHE DIAGNOSTICS DHEAS 463341

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR