BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CYFRA 21-1

    MDR report key: 19053800 · Received April 5, 2024

    Report

    Report Number
    1823260-2024-01054
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Date of Event
    March 13, 2024
    Report Date
    April 23, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    OVK
    PMA / PMN Number
    K160915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS REQUESTED FOR INVESTIGATION BUT NOT PROVIDED. THE INSTRUMENT DATA SHOWED NO FLAGS OR ALARMS. A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE E601 MODULE SERIAL NUMBER WAS (B)(6) . QC WAS ACCEPTABLE BUT THE CALIBRATION WAS NOT ACCEPTABLE. THE MEASURING CELL HAS BEEN USED FOR ABOUT 2 YEARS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS CYFRA 21-1 ASSAY ON A COBAS 6000 E601 IMMUNOASSAY ANALYZER WHEN COMPARED TO A NON-ROCHE (MINDRAY) ANALYZER. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 6.6 NG/ML. REPEAT RESULT: 3.58 NG/ML (TESTED ON MINDRAY). SAMPLE 2 (PATIENT 2): INITIAL RESULT: 6.4 NG/ML. REPEAT RESULT: 3.72 NG/ML (TESTED ON MINDRAY). THE CUSTOMER QUESTIONED THE INITIAL RESULTS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE SAMPLES WERE REPEATED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545302 ELECSYS CYFRA 21-1 CYTOKERATIN FRAGMENTS 21-1 EIA OVK ROCHE DIAGNOSTICS 711310

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male