BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS DHEA-S

    MDR report key: 6901083 · Received September 28, 2017

    Report

    Report Number
    1823260-2017-02139
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    September 8, 2017
    Report Date
    October 12, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKC
    PMA / PMN Number
    K003174
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES FROM THE TWO PATIENTS WERE PROVIDED FOR INVESTIGATION. INVESTIGATIONS OF THE SAMPLES DETERMINED THAT THEY CONTAIN AN INTERFERENT TO THE STREPTAVIDIN USED IN THE FT3, FT4, AND DHEA-S ASSAYS. THIS LIMITATION IS COVERED IN PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR TWO PATIENT SAMPLES TESTED FOR ELECSYS FT3 III (FT3), THE ELECSYS FT4 II ASSAY (FT4), AND ELECSYS DHEA-S (DHEA-S) ON A COBAS 8000 E 602 MODULE (E602). ALL RESULTS WERE HIGHER WHEN COMPARED TO RESULTS FROM COMPETITOR SYSTEMS (LIAISON, ABBOTT, AND AN UNKNOWN METHOD). THE CUSTOMER BELIEVES THAT THE SAMPLE CONTAINS AN INTERFERENT TO THE ROCHE ASSAYS. THIS MEDWATCH WILL APPLY TO THE DHEA-S ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4) FOR INFORMATION RELATED TO THE FT3 ASSAY AND REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4) FOR INFORMATION RELATED TO THE FT4 ASSAY REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE FIRST PATIENT'S ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE CONSIDERED TO BE IMPLAUSIBLE. THEREFORE, THE FIRST PATIENT'S SAMPLE WAS REPEATED USING COMPETITOR METHODS. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. TREATMENT DECISIONS FOR BOTH PATIENTS WERE MADE BASED ON RESULTS FROM THE COMPETITOR SYSTEMS. THE E602 ANALYZER SERIAL NUMBER WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682787 ELECSYS DHEA-S DEHYDROEPIANDROSTERONE (FREE AND SULFATE) TEST SYSTEM JKC ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1