BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CYFRA 21-1

    MDR report key: 10727186 · Received October 23, 2020

    Report

    Report Number
    1823260-2020-02631
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    September 28, 2020
    Report Date
    December 8, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    OVK
    PMA / PMN Number
    K160915
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOUND THAT THE LUMIPULSE RESULTS AND ABBOTT ARCHITECT RESULTS ARE COMPARABLE AND THE ELECSYS RESULTS WERE FOUND TO BE HIGHER. THE RESULTS FROM THE INVESTIGATION INDICATED THAT THE HIGHER RESULTS FOR SAMPLES NUMBERS 37 AND 41 WERE RECORDED WITH THE COMPETITOR ASSAYS AS WELL. PRODUCT LABELING STATES: "THE MEASURED CYFRA 21-1 VALUE OF A PATIENT¿S SAMPLE CAN VARY DEPENDING ON THE TESTING PROCEDURE USED. THE LABORATORY FINDING MUST THEREFORE ALWAYS CONTAIN A STATEMENT ON THE CYFRA 21-1 ASSAY METHOD USED. CYFRA 21-1 VALUES DETERMINED ON PATIENT SAMPLES BY DIFFERENT TESTING PROCEDURES CANNOT BE DIRECTLY COMPARED WITH ONE ANOTHER AND COULD BE THE CAUSE OF ERRONEOUS MEDICAL INTERPRETATIONS. IF THERE IS A CHANGE IN THE CYFRA 21-1 ASSAY PROCEDURE USED WHILE MONITORING THERAPY, THEN THE CYFRA 21-1 VALUES OBTAINED UPON CHANGING OVER TO THE NEW PROCEDURE MUST BE CONFIRMED BY PARALLEL MEASUREMENTS WITH BOTH METHODS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE CYFRA 21-1 ELECSYS RESULTS FOR 13 PATIENT SAMPLES ON A COBAS E 411 IMMUNOASSAY ANALYZER, SERIAL NUMBER (B)(4). THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194959 ELECSYS CYFRA 21-1 CYTOKERATIN FRAGMENTS 21-1 EIA OVK ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1