BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CYFRA 21-1

    MDR report key: 15177401 · Received August 5, 2022

    Report

    Report Number
    1823260-2022-02312
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    July 1, 2022
    Report Date
    September 1, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    OVK
    PMA / PMN Number
    K160915
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELD D4, EXPIRATION DATE WAS UPDATED. CALIBRATION AND QC WERE ACCEPTABLE. SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED FOR ELECSYS CYFRA 21-1 (CYFRA 21-1) ON A COBAS 6000 E 601 MODULE. THE INITIAL RESULT FROM THE E601 MODULE WAS 6.12 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2022 THE PATIENT WENT TO A DIFFERENT HOSPITAL WHERE A NEW SAMPLE WAS DRAWN AND THE RESULT BY THE ELECSYS METHOD WAS 1.8 NG/ML. ON (B)(6) 2022 THE CUSTOMER REPEATED THE ORIGINAL SAMPLE ON THE E601 MODULE AND THE RESULT WAS 5.84 NG/ML. THE CUSTOMER SENT THE SAMPLE TO TWO OTHER HOSPITALS WHERE THE RESULTS BY THE ELECSYS METHOD ON (B)(6) 2022 WERE 5.41 NG/ML AND 5.02 NG/ML. AN ALIQUOT OF THE ORIGINAL SAMPLE WAS ALSO SENT TO THE SAME HOSPITAL WHERE THE PATIENT HAD GONE ON (B)(6) 2022 AND THE RESULT BY THE ELECSYS METHOD WAS 4.73 NG/ML. THE CUSTOMER THINKS THE RESULTS SHOULD BE LOWER AS ALL THE OTHER TUMOR MARKER RESULTS FOR THE PATIENT WERE NORMAL. THE E601 MODULE SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691054 ELECSYS CYFRA 21-1 CYTOKERATIN FRAGMENTS 21-1 EIA OVK ROCHE DIAGNOSTICS NA 55188502

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female