BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CYFRA 21-1

    MDR report key: 16567062 · Received March 17, 2023

    Report

    Report Number
    1823260-2023-00863
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 21, 2023
    Report Date
    April 28, 2023
    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

    A SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS B3 AND B6 WERE UPDATED.

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLE WAS INVESTIGATED AND NO CAUSE FOR THE RESULT DISCREPANCIES COULD BE FOUND. THE CUSTOMER¿S RESULTS WERE CONFIRMED. NO PRODUCT ISSUE WAS FOUND AND THE REAGENT PERFORMED WITHIN SPECIFICATIONS. A GENERAL REAGENT-RELATED ISSUE COULD BE EXCLUDED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH RESULTS FOR MULTIPLE ASSAYS FOR ONE PATIENT FROM COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND THE DOCTOR BELIEVED THE RESULTS DID NOT MATCH THE MEDICAL IMAGING RESULTS AND QUESTIONED IF THERE WERE INTERFERING SUBSTANCES. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. REFER TO THE MEDWATCHES WITH THE FOLLOWING A1 PATIENT IDENTIFIERS FOR ALL INVOLVED ASSAYS: (B)(6) FOR THE CA 15-3 ASSAY. (B)(6) FOR THE CEA ASSAY. (B)(6) FOR THE CYFRA 21-1 ASSAY. (B)(6) FOR THE CA19-9 ASSAY. (B)(6) FOR THE CA 125 ASSAY. (B)(6) FOR THE AFP ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664992 ELECSYS CYFRA 21-1 TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM. OVK ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female